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69 rows where docket_id = "FDA-2010-P-0614" sorted by posted_date descending
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- FDA 69
| id | agency_id | docket_id | title | document_type | subtype | posted_date ▲ | posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| FDA-2010-P-0614-0079 | FDA | None FDA-2010-P-0614 | Attachment 1 - "Supporting Research and Development to Promote Economic Growth: The Federal Government's Role" - [Mutual Pharmaceutical Company, Inc., (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | Reply Comment (RC) | 2011-06-21T04:00:00Z | 2011 | 6 | 2011-06-21T15:21:02Z | 0 | 0 | 0900006480d0391b | |||
| FDA-2010-P-0614-0080 | FDA | None FDA-2010-P-0614 | Attachment 2 - "Frequently Asked Questions About Drug Shortage" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | Reply Comment (RC) | 2011-06-21T04:00:00Z | 2011 | 6 | 2011-06-21T15:21:02Z | 0 | 0 | 0900006480d0391c | |||
| FDA-2010-P-0614-0081 | FDA | None FDA-2010-P-0614 | Attachment 3 - "Questions and Answers: Delayed-Release Pancreatic Enzyme Product Receives FDA Approval" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | Reply Comment (RC) | 2011-06-21T04:00:00Z | 2011 | 6 | 2011-06-21T15:21:02Z | 0 | 0 | 0900006480d0391d | |||
| FDA-2010-P-0614-0077 | FDA | None FDA-2010-P-0614 | Attachment 6 - "StatCrunch re FMF: Patients' Responses to Colchine, February 22, 2010" | Supporting & Related Material | Reply Comment (RC) | 2011-06-17T04:00:00Z | 2011 | 6 | 2011-06-17T22:54:24Z | 0 | 0 | 0900006480c7a19f | |||
| FDA-2010-P-0614-0075 | FDA | None FDA-2010-P-0614 | Attachment 4 - "e-Correspondence, re Westward, etc., December 15, 2009" | Supporting & Related Material | Reply Comment (RC) | 2011-06-17T04:00:00Z | 2011 | 6 | 2011-06-17T22:47:45Z | 0 | 0 | 0900006480c79c28 | |||
| FDA-2010-P-0614-0076 | FDA | None FDA-2010-P-0614 | Attachment 5 - "e-Correspondence re Colchicine Assistance Program, February 22, 2010" | Supporting & Related Material | Reply Comment (RC) | 2011-06-17T04:00:00Z | 2011 | 6 | 2011-06-17T22:47:45Z | 0 | 0 | 0900006480c79c29 | |||
| FDA-2010-P-0614-0074 | FDA | None FDA-2010-P-0614 | Attachment 2 - "Declaration and Curriculum Vitae, Dr. Thomas J. Maronick, DBA, JD" | Supporting & Related Material | Reply Comment (RC) | 2011-06-17T04:00:00Z | 2011 | 6 | 2011-06-17T22:47:44Z | 0 | 0 | 0900006480c79c26 | |||
| FDA-2010-P-0614-0072 | FDA | None FDA-2010-P-0614 | FDA/CDER to Sidley Austin LLP - Petition Partial Approval and Denial | Other | PPAD-Petition Partial Approval and Denial | 2011-05-25T04:00:00Z | 2011 | 5 | 2011-05-25T04:00:00Z | 2013-07-27T23:54:06Z | 0 | 0 | 0900006480e3245f | ||
| FDA-2010-P-0614-0070 | FDA | None FDA-2010-P-0614 | Appendix 2 - "American College of Rheumatory to FDA re huge price increases in the Colchicine Market, December 18, 2009" - [West-Ward Pharmaceutical Corporation (Arnall Golden Gregory LLP) - Supplement] re FDA-2010-P-0614-0069 | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-05-17T04:00:00Z | 2011 | 5 | 2011-05-17T21:25:51Z | 0 | 0 | 0900006480c79ac3 | |||
| FDA-2010-P-0614-0071 | FDA | None FDA-2010-P-0614 | Appendix 3 - "Summary of January 21 Teleconference with FDA Regarding Colchicine" - [West-Ward Pharmaceutical Corporation (Arnall Golden Gregory LLP) - Supplement] re FDA-2010-P-0614-0069 | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-05-17T04:00:00Z | 2011 | 5 | 2011-05-17T21:26:28Z | 0 | 0 | 0900006480c79ac4 | |||
| FDA-2010-P-0614-0069 | FDA | None FDA-2010-P-0614 | West-Ward Pharmaceutical Corporation (Arnall Golden Gregory LLP) - Supplement | Other | SUP-Supplement | 2011-05-17T04:00:00Z | 2011 | 5 | 2011-05-17T04:00:00Z | 2013-07-27T23:52:55Z | 0 | 0 | 0900006480c79ac1 | ||
| FDA-2010-P-0614-0067 | FDA | None FDA-2010-P-0614 | Appendix 6 - "Qualaquin, URL Pharma" - [West-Ward Pharmaceutical Corporation (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-05-10T04:00:00Z | 2011 | 5 | 2011-05-10T22:29:16Z | 0 | 0 | 0900006480c40c2f | |||
| FDA-2010-P-0614-0062 | FDA | None FDA-2010-P-0614 | Appendix 1 - "Motion to Dismiss, King Pharmaceuticals, Inc., and Jones Pharma, Inc., v. FDA, et al., US District Court for the District of Columbia, No.1:04cv01058(RBW)" - [West-Ward Pharmaceutical Corporation (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-05-10T04:00:00Z | 2011 | 5 | 2011-05-10T22:04:49Z | 0 | 0 | 0900006480c40c2a | |||
| FDA-2010-P-0614-0063 | FDA | None FDA-2010-P-0614 | Appendix 2 - "Colchicine, E-mail Message, February 23, 2011" - [West-Ward Pharmaceutical Corporation (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-05-10T04:00:00Z | 2011 | 5 | 2011-05-10T22:14:55Z | 0 | 0 | 0900006480c40c2b | |||
| FDA-2010-P-0614-0065 | FDA | None FDA-2010-P-0614 | Appendix 4 - "Patent Information Submitted Upon and After Approval of an NDA or Supplement, Form FDA 3542" - [West-Ward Pharmaceutical Corporation (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-05-10T04:00:00Z | 2011 | 5 | 2011-05-10T22:18:16Z | 0 | 0 | 0900006480c40c2d | |||
| FDA-2010-P-0614-0066 | FDA | None FDA-2010-P-0614 | Appendix 5 - "Complaint for Declaratory Judgement, Mutual Pharmaceutical Company v. West-Ward Pharmaceutical Corporation, April 21, 2011" - [West-Ward Pharmaceutical Corporation (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-05-10T04:00:00Z | 2011 | 5 | 2011-05-10T22:24:52Z | 0 | 0 | 0900006480c40c2e | |||
| FDA-2010-P-0614-0061 | FDA | None FDA-2010-P-0614 | West-Ward Pharmaceutical Corporation (Arnall Golden Gregory LLP) - Supplement | Other | SUP-Supplement | 2011-05-10T04:00:00Z | 2011 | 5 | 2013-08-11T04:45:41Z | 0 | 0 | 0900006480c40772 | |||
| FDA-2010-P-0614-0064 | FDA | None FDA-2010-P-0614 | Appendix 3 - "U.S. Patent Nos. 7,619,004 and 7,820,681" - [West-Ward Pharmaceutical Corporation (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-05-10T04:00:00Z | 2011 | 5 | 2011-05-10T22:14:19Z | 0 | 0 | 0900006480c40c2c | |||
| FDA-2010-P-0614-0058 | FDA | None FDA-2010-P-0614 | Tab 20 - "FDA/CDER Chemistry Review(s) for NDA 21-342, Levo-T® (levothyroxine sodium tablets, USP)" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:42Z | 0 | 0 | 0900006480c2b452 | |||
| FDA-2010-P-0614-0048 | FDA | None FDA-2010-P-0614 | Tab 10 - "FDA News Release: FDA Orders Halt to Marketing of Unapproved Single-Ingredient Oral Colchicine" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:23Z | 0 | 0 | 0900006480c263c4 | |||
| FDA-2010-P-0614-0054 | FDA | None FDA-2010-P-0614 | Tab 16 - "FDA/CDER Response to Pennie & Edmonds, LLP, Oct. 1, 2003" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:35Z | 0 | 0 | 0900006480c27c69 | |||
| FDA-2010-P-0614-0042 | FDA | None FDA-2010-P-0614 | Tab 1 - "Transcript of FDA's Marketed Unapproved Drug Workshop, Pages 278-279, (Jan. 9, 2007)" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:11Z | 0 | 0 | 0900006480c2617a | |||
| FDA-2010-P-0614-0043 | FDA | None FDA-2010-P-0614 | Tab 3 - "FDA/CDER Summary Review for Regulatory Action for NDA 22-353, Colcrys" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:13Z | 0 | 0 | 0900006480c2617c | |||
| FDA-2010-P-0614-0049 | FDA | None FDA-2010-P-0614 | Tab 11 - "Package Insert for Probenecid and Colchicine Tablets (Watson Laboratories, Inc.)" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:25Z | 0 | 0 | 0900006480c26b62 | |||
| FDA-2010-P-0614-0044 | FDA | None FDA-2010-P-0614 | Tab 5 - "Approved Product Labeling for Colchicine Tablet (Rebel Distributors Corp.)" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:15Z | 0 | 0 | 0900006480c2617e | |||
| FDA-2010-P-0614-0045 | FDA | None FDA-2010-P-0614 | Tab 6 - "Approved Product Labeling for Colchicine Tablet (RemedyRepack, Inc.)" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:17Z | 0 | 0 | 0900006480c2617f | |||
| FDA-2010-P-0614-0051 | FDA | None FDA-2010-P-0614 | Tab 13 - "FDA/CDER Administrative and Correspondence Documents Related to NDA 22-353, Colcrys" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:29Z | 0 | 0 | 0900006480c27c66 | |||
| FDA-2010-P-0614-0055 | FDA | None FDA-2010-P-0614 | Tab 17 - "FDA/CDER Chemistry Review(s) for NDA 21-116, Thyro-Tabs® (levothyroxine sodium tablets, USP)" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:36Z | 0 | 0 | 0900006480c27c6a | |||
| FDA-2010-P-0614-0046 | FDA | None FDA-2010-P-0614 | Tab 7 - "Approved Prescribing Information for Colchicine (Colchicine Tablet) (West-ward Pharmaceutical Corp.)" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:19Z | 0 | 0 | 0900006480c263bf | |||
| FDA-2010-P-0614-0050 | FDA | None FDA-2010-P-0614 | Tab 12 - "FDA/CDER Cross Discipline Team Leader Review of NDA 22-353, Colcrys (Colchicine)" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:27Z | 0 | 0 | 0900006480c27c63 | |||
| FDA-2010-P-0614-0060 | FDA | None FDA-2010-P-0614 | Tab 23 - "FDA/CDER Cross Discipline Team Leader Review for NDA 22-351, Colcrys (colchicine)" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:46Z | 0 | 0 | 0900006480c2b455 | |||
| FDA-2010-P-0614-0047 | FDA | None FDA-2010-P-0614 | Tab 9 - "Disclosure of FOIA Request Log for Control No. 2009-6835, August 26, 2009 " - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:21Z | 0 | 0 | 0900006480c263c3 | |||
| FDA-2010-P-0614-0052 | FDA | None FDA-2010-P-0614 | Tab 14 - "FDA/CDER Response to Osmotica Pharmaceutical Corp., Nov. 25, 2008" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:31Z | 0 | 0 | 0900006480c27c67 | |||
| FDA-2010-P-0614-0057 | FDA | None FDA-2010-P-0614 | Tab 19 - "FDA/CDER Chemistry Review(s) for NDA 21-402, Synthroid® (levothyroxine sodium tablets, USP)" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:40Z | 0 | 0 | 0900006480c27c6c | |||
| FDA-2010-P-0614-0059 | FDA | None FDA-2010-P-0614 | Tab 22 - "Chemistry Review(s) for NDA 21-137, Levolet® (levothyroxine sodium tablets, USP)" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:44Z | 0 | 0 | 0900006480c2b454 | |||
| FDA-2010-P-0614-0056 | FDA | None FDA-2010-P-0614 | Tab 18 - "FDA/CDER Chemistry Review(s) for NDA 21-292, Novothyrox (levothyroxine sodium tablet, USP)" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:38Z | 0 | 0 | 0900006480c27c6b | |||
| FDA-2010-P-0614-0053 | FDA | None FDA-2010-P-0614 | Tab 15 - "FDA/CDER Response to Osmotica Pharmaceutical Corp., Jan. 21, 2010" - [Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) - Reply Comment] | Supporting & Related Material | RC-Reply Comment (Supporting and Related Material) | 2011-04-27T04:00:00Z | 2011 | 4 | 2011-04-27T19:20:33Z | 0 | 0 | 0900006480c27c68 | |||
| FDA-2010-P-0614-0033 | FDA | None FDA-2010-P-0614 | Appendix 11 - "November 20, 2004 Letter From Galson (FDA) to Beers and Cavanaugh Regarding Docket No. 2004P-0386" - [West-Ward Pharmaceutical Group (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-04-22T04:00:00Z | 2011 | 4 | 2011-04-22T22:42:11Z | 0 | 0 | 0900006480c2da29 | |||
| FDA-2010-P-0614-0030 | FDA | None FDA-2010-P-0614 | Appendix 8 - "Draft Guidance for Industry: Application Covered by Section 505(b)(2), (October 1999)" - [West-Ward Pharmaceutical Group (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-04-22T04:00:00Z | 2011 | 4 | 2011-04-22T22:34:11Z | 0 | 0 | 0900006480c2da11 | |||
| FDA-2010-P-0614-0041 | FDA | None FDA-2010-P-0614 | Appendix 21 - "Rockoff, An Old Gout Drug Gets New Life an a New Price, Riling Patients, Drug, July 7, 2010" - [West-Ward Pharmaceutical Group (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-04-22T04:00:00Z | 2011 | 4 | 2011-04-22T23:32:51Z | 0 | 0 | 0900006480c2e382 | |||
| FDA-2010-P-0614-0037 | FDA | None FDA-2010-P-0614 | Appendix 17 - "Teva Pharms., USA, Inc. v. FDA, 182 F. 3d 1003, (D.C. Cir.1999)- [West-Ward Pharmaceutical Group (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-04-22T04:00:00Z | 2011 | 4 | 2011-04-22T23:04:16Z | 0 | 0 | 0900006480c2e19a | |||
| FDA-2010-P-0614-0038 | FDA | None FDA-2010-P-0614 | Appendix 18 - "Civil Minutes From Mutual Pharm. Co, Inc. v. West-Ward Pharm. Corp. Et al, Civ. Action 09-05700 (C.D. Cal. 2010)" - [West-Ward Pharmaceutical Group (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-04-22T04:00:00Z | 2011 | 4 | 2011-04-22T23:06:40Z | 0 | 0 | 0900006480c2e19b | |||
| FDA-2010-P-0614-0039 | FDA | None FDA-2010-P-0614 | Appendix 20 - "Miller, The Price of Gout Drug Colchicine, Goes Up, April 20, 2010" - [West-Ward Pharmaceutical Group (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-04-22T04:00:00Z | 2011 | 4 | 2011-04-22T23:11:25Z | 0 | 0 | 0900006480c2e381 | |||
| FDA-2010-P-0614-0036 | FDA | None FDA-2010-P-0614 | Appendix 14 - "Redacted Letter From Chowdhury (FDA) to West-Ward Pharmaceutical Corporation" - [West-Ward Pharmaceutical Group (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-04-22T04:00:00Z | 2011 | 4 | 2011-04-22T22:55:46Z | 0 | 0 | 0900006480c2e197 | |||
| FDA-2010-P-0614-0032 | FDA | None FDA-2010-P-0614 | Appendix 10 - "FDA, Clinical Review for NDA 22-353" - [West-Ward Pharmaceutical Group (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-04-22T04:00:00Z | 2011 | 4 | 2011-04-22T22:41:47Z | 0 | 0 | 0900006480c2da28 | |||
| FDA-2010-P-0614-0031 | FDA | None FDA-2010-P-0614 | Appendix 9 - "FDA, Summary Review for Regulatory Action for NDA 22-353" - [West-Ward Pharmaceutical Group (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-04-22T04:00:00Z | 2011 | 4 | 2011-04-22T22:36:17Z | 0 | 0 | 0900006480c2da12 | |||
| FDA-2010-P-0614-0034 | FDA | None FDA-2010-P-0614 | Appendix 12 - "August 1, 2008 Letter from Mutual Pharmaceutical Company, Inc. re: Citizen Petition Submission (Docket No. FDA-2008-P-0442)" - [West-Ward Pharmaceutical Group (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-04-22T04:00:00Z | 2011 | 4 | 2011-04-22T22:45:19Z | 0 | 0 | 0900006480c2e0ac | |||
| FDA-2010-P-0614-0028 | FDA | None FDA-2010-P-0614 | West-Ward Pharmaceutical Group (Arnall Golden Gregory LLP) - Supplement | Other | SUP-Supplement | 2011-04-22T04:00:00Z | 2011 | 4 | 2011-04-22T04:00:00Z | 2013-07-27T23:50:28Z | 0 | 0 | 0900006480c2d939 | ||
| FDA-2010-P-0614-0035 | FDA | None FDA-2010-P-0614 | Appendix 13 - "December 18, 2009 Letter from Stanley Cohen, MD to Janet Woodcock re: Removal of Unapproved Colchicine" - [West-Ward Pharmaceutical Group (Arnall Golden Gregory LLP) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-04-22T04:00:00Z | 2011 | 4 | 2011-04-22T22:53:40Z | 0 | 0 | 0900006480c2e196 | |||
| FDA-2010-P-0614-0026 | FDA | None FDA-2010-P-0614 | Janine Jagger, M.P.H., Ph.D., to FDA - Letter | Other | LET-Letter | 2011-04-11T04:00:00Z | 2011 | 4 | 2011-04-11T04:00:00Z | 2013-08-11T01:40:49Z | 0 | 0 | 0900006480c18eec | ||
| FDA-2010-P-0614-0023 | FDA | None FDA-2010-P-0614 | Mutual Pharmaceutical Company, Inc. (Sidley Austin LLP) to FDA/CDER - Letter | Other | LET-Letter | 2011-03-18T04:00:00Z | 2011 | 3 | 2011-03-18T04:00:00Z | 2013-07-27T23:46:50Z | 0 | 0 | 0900006480c025de | ||
| FDA-2010-P-0614-0019 | FDA | None FDA-2010-P-0614 | Tab 16 - "FDA Administrative and Correspondence Documents for NDA 22-351: Minutes from Type B Pre-IND Meeting Between FDA and Mutual Pharmaceutical Company, Inc.," July 31, 2006 - [Sidley Austin, LLP - (Mutual Pharmaceutical Company, Inc.) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-01-20T05:00:00Z | 2011 | 1 | 2011-01-20T17:34:15Z | 0 | 0 | 0900006480bc1b4c | |||
| FDA-2010-P-0614-0011 | FDA | None FDA-2010-P-0614 | Tab 6 - FDA Information for Healthcare Professionals, "New Safety Information for Colchicine (Marketed as Colcrys)," July 30, 2009 - [Sidley Austin, LLP - (Mutual Pharmaceutical Company, Inc.) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-01-20T05:00:00Z | 2011 | 1 | 2011-01-20T17:34:02Z | 0 | 0 | 0900006480bc1ae1 | |||
| FDA-2010-P-0614-0014 | FDA | None FDA-2010-P-0614 | Tab 9 - "Letter from FDA's Center for Drug Evaluation and Research to Osmotica Pharmaceutical Corp. regarding Docket No. FDA-2008-P-0329," dated November 25, 2008 - [Sidley Austin, LLP - (Mutual Pharmaceutical Company, Inc.) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-01-20T05:00:00Z | 2011 | 1 | 2011-01-20T17:34:07Z | 0 | 0 | 0900006480bc1ae4 | |||
| FDA-2010-P-0614-0008 | FDA | None FDA-2010-P-0614 | Tab 1 - FDA Consumer Information, "New Label Information Affecting All Approved Protease Inhibitors for Treatment of HIV" - [Sidley Austin, LLP - (Mutual Pharmaceutical Company, Inc.) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-01-20T05:00:00Z | 2011 | 1 | 2011-01-20T17:30:41Z | 0 | 0 | 0900006480bc1745 | |||
| FDA-2010-P-0614-0012 | FDA | None FDA-2010-P-0614 | Tab 7 - "Letter from FDA's Center for Drug Evaluation and Research to Arnold & Porter, LLP and Patterson, Belknap, Webb & Tyler, LLP regarding Docket No. 2004P-0386," dated November 30, 2004 - [Sidley Austin, LLP - (Mutual Pharmaceutical Company, Inc.) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-01-20T05:00:00Z | 2011 | 1 | 2011-01-20T17:34:03Z | 0 | 0 | 0900006480bc1ae2 | |||
| FDA-2010-P-0614-0015 | FDA | None FDA-2010-P-0614 | Tab 12 - "Allopurinol Package Insert" - [Sidley Austin, LLP - (Mutual Pharmaceutical Company, Inc.) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-01-20T05:00:00Z | 2011 | 1 | 2011-01-20T17:34:09Z | 0 | 0 | 0900006480bc1ae9 | |||
| FDA-2010-P-0614-0017 | FDA | None FDA-2010-P-0614 | Tab 14 - "FDA Clinical Review for NADA 22-353" dated August 5, 2009 (Relevant Pages) - [Sidley Austin, LLP - (Mutual Pharmaceutical Company, Inc.) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-01-20T05:00:00Z | 2011 | 1 | 2011-01-20T17:34:12Z | 0 | 0 | 0900006480bc1b48 | |||
| FDA-2010-P-0614-0018 | FDA | None FDA-2010-P-0614 | Tab 15 - "FDA Clinical Pharmacology and Biopharmaceutics Review(s) for NDA 22-352," dated November 26, 2008 (Relevant Pages) - [Sidley Austin, LLP - (Mutual Pharmaceutical Company, Inc.) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-01-20T05:00:00Z | 2011 | 1 | 2011-01-20T17:34:14Z | 0 | 0 | 0900006480bc1b4b | |||
| FDA-2010-P-0614-0010 | FDA | None FDA-2010-P-0614 | Tab 3 - "Declaration of E. Marro in Support of Defendant West-Ward Pharmaceutical Corp.'s Response in Opposition to Plaintiff's Motion for Preliminary Injunction" - [Sidley Austin, LLP - (Mutual Pharmaceutical Company, Inc.) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-01-20T05:00:00Z | 2011 | 1 | 2011-01-20T17:34:00Z | 0 | 0 | 0900006480bc1908 | |||
| FDA-2010-P-0614-0016 | FDA | None FDA-2010-P-0614 | Tab 13 - "Letter from FDA's Center for Drug Evaluation and Research to Covington & Burling (Wyeth Pharmaceuticals) regarding Docket No. 2003P-0518" dated September 20, 2004 - [Sidley Austin, LLP - (Mutual Pharmaceutical Company, Inc.) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-01-20T05:00:00Z | 2011 | 1 | 2011-01-20T17:34:10Z | 0 | 0 | 0900006480bc1b45 | |||
| FDA-2010-P-0614-0009 | FDA | None FDA-2010-P-0614 | Tab 2 - "Open Letter from FDA's Center for Drug Evaluation and Research regarding Unapproved Colchicine" - [Sidley Austin, LLP - (Mutual Pharmaceutical Company, Inc.) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-01-20T05:00:00Z | 2011 | 1 | 2011-01-20T17:33:58Z | 0 | 0 | 0900006480bc1906 | |||
| FDA-2010-P-0614-0013 | FDA | None FDA-2010-P-0614 | Tab 8 - "Letter from FDA's Center for Drug Evaluation and Research to Sanzo, et. al., regarding Docket Nos. 2001P-0323, 2002P-0447, and 2003P-0408," dated October 14, 2004 - [Sidley Austin, LLP - (Mutual Pharmaceutical Company, Inc.) - Supplement] | Supporting & Related Material | SUP-Supplement (Supporting and Related Material) | 2011-01-20T05:00:00Z | 2011 | 1 | 2011-01-20T17:34:05Z | 0 | 0 | 0900006480bc1ae3 | |||
| FDA-2010-P-0614-0007 | FDA | None FDA-2010-P-0614 | Sidley Austin, LLP [Mutual Pharmaceutical Company, Inc.] - Supplement | Other | SUP-Supplement | 2011-01-19T05:00:00Z | 2011 | 1 | 2011-01-19T05:00:00Z | 2013-08-11T03:12:27Z | 0 | 0 | 0900006480bc1744 | ||
| FDA-2010-P-0614-0004 | FDA | None FDA-2010-P-0614 | Attachment 2 Highlights of Prescribing Information [Mutual Pharmaceutical Company, Inc. Citizen petition] | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2010-12-08T05:00:00Z | 2010 | 12 | 2010-12-08T21:18:40Z | 0 | 0 | 0900006480baa7f3 | |||
| FDA-2010-P-0614-0006 | FDA | None FDA-2010-P-0614 | Attachment 4 Letter From Center for Drugs [Mutual Pharmaceutical Company, Inc. Citizen petition] | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2010-12-08T05:00:00Z | 2010 | 12 | 2010-12-08T21:18:13Z | 0 | 0 | 0900006480baa852 | |||
| FDA-2010-P-0614-0001 | FDA | None FDA-2010-P-0614 | Acknowledgement Letter to Sidley Austin LLP [Mutual Pharmaceutical Company, Inc.] | Other | ACK-Acknowledgement Letter | 2010-12-08T05:00:00Z | 2010 | 12 | 2010-12-08T05:00:00Z | 2010-12-08T21:01:59Z | 0 | 0 | 0900006480baa855 | ||
| FDA-2010-P-0614-0003 | FDA | None FDA-2010-P-0614 | Attachment 1 Colchicine Tablets USP [Mutual Pharmaceutical Company, Inc. Citizen petition] | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2010-12-08T05:00:00Z | 2010 | 12 | 2024-11-12T05:00:59Z | 0 | 0 | 0900006480baa773 | |||
| FDA-2010-P-0614-0005 | FDA | None FDA-2010-P-0614 | Attachment 3 Marion Merrell Dow, Inc. et al Plaintiffs, V. Hoechst-Roussel Pharmaceuticals, Inc. Defendant [Mutual Pharmaceutical Company, Inc. Citizen petition] | Supporting & Related Material | CP-Citizen Petition (Supporting & Related Materials) | 2010-12-08T05:00:00Z | 2010 | 12 | 2010-12-08T21:16:39Z | 0 | 0 | 0900006480baa774 |
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id TEXT PRIMARY KEY,
agency_id TEXT,
docket_id TEXT REFERENCES dockets(id),
title TEXT,
document_type TEXT,
subtype TEXT,
posted_date TEXT,
posted_year INTEGER,
posted_month INTEGER,
comment_start_date TEXT,
comment_end_date TEXT,
last_modified TEXT,
fr_doc_num TEXT,
open_for_comment INTEGER,
withdrawn INTEGER,
object_id TEXT
);
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CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;