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withdrawn,object_id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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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,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