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35 rows where docket_id = "FDA-2008-N-0474" sorted by posted_date descending
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document_type 4
agency_id 1
- FDA 35
| 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| posted_year | posted_month | comment_start_date | comment_end_date | last_modified | fr_doc_num | open_for_comment | withdrawn | object_id |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-2008-N-0474-0038 | FDA | None FDA-2008-N-0474 | L'Oreal Response Letter from October 2015 Submission | Other | Answer | 2016-06-27T04:00:00Z | 2016 | 6 | 2016-06-27T04:00:00Z | 2016-06-27T18:31:56Z | 0 | 0 | 0900006482071493 | ||
| FDA-2008-N-0474-0037 | FDA | None FDA-2008-N-0474 | Letter from FDA CDER to L'Oreal USA Products, Inc. | Other | Letter(s) | 2015-12-14T05:00:00Z | 2015 | 12 | 2015-12-14T05:00:00Z | 2015-12-14T20:53:46Z | 0 | 0 | 0900006481da43dc | ||
| FDA-2008-N-0474-0036 | FDA | None FDA-2008-N-0474 | Letter from L'Oreal USA Products Inc. to FDA CDER | Other | Letter(s) | 2015-10-13T04:00:00Z | 2015 | 10 | 2015-10-13T04:00:00Z | 2015-10-13T13:22:00Z | 0 | 0 | 0900006481cc3e87 | ||
| FDA-2008-N-0474-0035 | FDA | None FDA-2008-N-0474 | Advice Letter from FDA CDER to L'Oreal USA Products Inc | Other | Letter(s) | 2015-09-02T04:00:00Z | 2015 | 9 | 2015-09-02T04:00:00Z | 2015-09-02T15:26:52Z | 0 | 0 | 0900006481c50275 | ||
| FDA-2008-N-0474-0034 | FDA | None FDA-2008-N-0474 | Response to FDA Meeting Minutes May 11. 2015 from L'Oreal USA | Other | Minutes | 2015-07-21T04:00:00Z | 2015 | 7 | 2015-07-21T04:00:00Z | 2015-07-21T15:05:49Z | 0 | 0 | 0900006481b954ba | ||
| FDA-2008-N-0474-0033 | FDA | None FDA-2008-N-0474 | Memorandum of Meeting Minutes May 11, 2015 between FDA CDER and L'Oreal USA Products Inc. | Other | Memorandum | 2015-06-12T04:00:00Z | 2015 | 6 | 2015-06-12T04:00:00Z | 2015-06-12T14:51:44Z | 0 | 0 | 0900006481b30d22 | ||
| FDA-2008-N-0474-0029 | FDA | None FDA-2008-N-0474 | Request for a Meeting from L'Oreal USA Products, Inc to FDA CDER | Other | Request | 2015-05-01T04:00:00Z | 2015 | 5 | 2015-05-01T04:00:00Z | 2015-05-01T14:31:21Z | 0 | 0 | 0900006481a6df2d | ||
| FDA-2008-N-0474-0032 | FDA | None FDA-2008-N-0474 | Response from FDA CDER to L'Oreal USA Products Inc | Other | Response(s) | 2015-05-01T04:00:00Z | 2015 | 5 | 2015-05-01T04:00:00Z | 2015-05-01T16:54:55Z | 0 | 0 | 0900006481ac7a72 | ||
| FDA-2008-N-0474-0024 | FDA | None FDA-2008-N-0474 | Reference 6 - International Conference on Harmonization (ICH), Guidance for Industry, The Need for Long-Term Rodent Carcinogenicity Studies of Pharmaceuticals S1A, March 1996 | Supporting & Related Material | Background Material | 2015-02-25T05:00:00Z | 2015 | 2 | 2015-02-25T16:00:53Z | 0 | 0 | 0900006481a113a5 | |||
| FDA-2008-N-0474-0019 | FDA | None FDA-2008-N-0474 | Reference 1 - FDA, Guidance for Industry, Photosafety Testing, May 2003 | Supporting & Related Material | Background Material | 2015-02-25T05:00:00Z | 2015 | 2 | 2015-02-25T15:59:35Z | 0 | 0 | 0900006481a113a0 | |||
| FDA-2008-N-0474-0028 | FDA | None FDA-2008-N-0474 | Reference 10 - International Conference on Harmonization (ICH) Guideline for Industry, Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies S3A, March 1995 | Supporting & Related Material | Background Material | 2015-02-25T05:00:00Z | 2015 | 2 | 2015-02-25T16:01:35Z | 0 | 0 | 0900006481a113b5 | |||
| FDA-2008-N-0474-0022 | FDA | None FDA-2008-N-0474 | Reference 4 - Schmidt et al, Photoallergic Contact Dermatitis Due to Combined UVB (4-Methylbenzylidene Camphor/Octyl Methoxycinnamate) and UVA (Benzophenone-3/Butyl Methoxydibenzoylmethane) Absorber Sensitization | Supporting & Related Material | Background Material | 2015-02-25T05:00:00Z | 2015 | 2 | 2015-02-25T16:00:22Z | 0 | 0 | 0900006481a113a3 | |||
| FDA-2008-N-0474-0018 | FDA | None FDA-2008-N-0474 | Over-the-Counter Sunscreen Drug Products—Regulatory Status of Ecamsule | Proposed Rule | Notice of Proposed Rulemaking (NPRM) | 2015-02-25T05:00:00Z | 2015 | 2 | 2015-02-25T05:00:00Z | 2015-04-14T03:59:59Z | 2015-05-02T02:02:23Z | 2015-03883 | 0 | 0 | 0900006481a16312 |
| FDA-2008-N-0474-0020 | FDA | None FDA-2008-N-0474 | Reference 2 - Leonard et al, The New Standard Battery of Photopatch Test in France. | Supporting & Related Material | Background Material | 2015-02-25T05:00:00Z | 2015 | 2 | 2015-02-25T16:00:03Z | 0 | 0 | 0900006481a113a1 | |||
| FDA-2008-N-0474-0027 | FDA | None FDA-2008-N-0474 | Reference 9 - International Conference on Harmonization (ICH) Harmonized Tripartite Guideline for Industry Detection of Toxicity to Reproduction for Medicinal Products & Toxicity to Male Fertility S5(R2), 2005 | Supporting & Related Material | Background Material | 2015-02-25T05:00:00Z | 2015 | 2 | 2015-02-25T16:01:25Z | 0 | 0 | 0900006481a113b4 | |||
| FDA-2008-N-0474-0021 | FDA | None FDA-2008-N-0474 | Reference 3 - Schauder et al, Contact and Photocontact Sensitivity to Sunscreens. Review of a 15-Year Experience and of the Literature | Supporting & Related Material | Background Material | 2015-02-25T05:00:00Z | 2015 | 2 | 2015-02-25T16:00:12Z | 0 | 0 | 0900006481a113a2 | |||
| FDA-2008-N-0474-0023 | FDA | None FDA-2008-N-0474 | Reference 5 - FDA Guidance for Industry, Guideline for the Format and Content of the Human Pharmacokinetics and Bioavailability Section of an Application, February 1987 | Supporting & Related Material | Background Material | 2015-02-25T05:00:00Z | 2015 | 2 | 2015-02-25T16:00:39Z | 0 | 0 | 0900006481a113a4 | |||
| FDA-2008-N-0474-0026 | FDA | None FDA-2008-N-0474 | Reference 8 - International Conference on Harmonization (ICH) Guidance for Industry - S1C(R2) Dose Selection for Carcinogenicity Studies (Revision 1), September 2008 | Supporting & Related Material | Background Material | 2015-02-25T05:00:00Z | 2015 | 2 | 2015-02-25T16:01:16Z | 0 | 0 | 0900006481a113a7 | |||
| FDA-2008-N-0474-0025 | FDA | None FDA-2008-N-0474 | Reference 7 - International Conference on Harmonization (ICH) Guidance for Industry, S1B Testing for Carcinogenicity of Pharmaceuticals, July 1997 | Supporting & Related Material | Background Material | 2015-02-25T05:00:00Z | 2015 | 2 | 2015-02-25T16:01:04Z | 0 | 0 | 0900006481a113a6 | |||
| FDA-2008-N-0474-0015 | FDA | None FDA-2008-N-0474 | Volume 9 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 | Supporting & Related Material | Background Material | 2015-02-19T05:00:00Z | 2015 | 2 | 2015-02-19T14:35:33Z | 0 | 0 | 0900006481a093e5 | |||
| FDA-2008-N-0474-0010 | FDA | None FDA-2008-N-0474 | Volume 4 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 | Supporting & Related Material | Background Material | 2015-02-19T05:00:00Z | 2015 | 2 | 2015-02-19T13:43:58Z | 0 | 0 | 0900006481a093e0 | |||
| FDA-2008-N-0474-0016 | FDA | None FDA-2008-N-0474 | Volume 10 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 | Supporting & Related Material | Background Material | 2015-02-19T05:00:00Z | 2015 | 2 | 2015-02-19T14:39:32Z | 0 | 0 | 0900006481a09458 | |||
| FDA-2008-N-0474-0009 | FDA | None FDA-2008-N-0474 | Volume 3 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 | Supporting & Related Material | Background Material | 2015-02-19T05:00:00Z | 2015 | 2 | 2015-02-19T13:43:51Z | 0 | 0 | 0900006481a093df | |||
| FDA-2008-N-0474-0008 | FDA | None FDA-2008-N-0474 | Volume 2 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 | Supporting & Related Material | Background Material | 2015-02-19T05:00:00Z | 2015 | 2 | 2015-02-19T13:43:42Z | 0 | 0 | 0900006481a093de | |||
| FDA-2008-N-0474-0013 | FDA | None FDA-2008-N-0474 | Volume 7 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 | Supporting & Related Material | Background Material | 2015-02-19T05:00:00Z | 2015 | 2 | 2015-02-19T14:07:52Z | 0 | 0 | 0900006481a093e3 | |||
| FDA-2008-N-0474-0012 | FDA | None FDA-2008-N-0474 | Volume 6 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 | Supporting & Related Material | Background Material | 2015-02-19T05:00:00Z | 2015 | 2 | 2015-02-19T13:57:17Z | 0 | 0 | 0900006481a093e2 | |||
| FDA-2008-N-0474-0011 | FDA | None FDA-2008-N-0474 | Volume 5 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 | Supporting & Related Material | Background Material | 2015-02-19T05:00:00Z | 2015 | 2 | 2015-02-19T13:49:38Z | 0 | 0 | 0900006481a093e1 | |||
| FDA-2008-N-0474-0017 | FDA | None FDA-2008-N-0474 | Volume 11 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 | Supporting & Related Material | Background Material | 2015-02-19T05:00:00Z | 2015 | 2 | 2015-02-19T15:10:39Z | 0 | 0 | 0900006481a09459 | |||
| FDA-2008-N-0474-0014 | FDA | None FDA-2008-N-0474 | Volume 8 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 | Supporting & Related Material | Background Material | 2015-02-19T05:00:00Z | 2015 | 2 | 2015-02-19T14:15:05Z | 0 | 0 | 0900006481a093e4 | |||
| FDA-2008-N-0474-0007 | FDA | None FDA-2008-N-0474 | Volume 1 Time and Extent Application (TEA) Part 2 from L'Oreal USA Products, Inc., re Data and Information for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated November 18, 2008, FDA-2008-N-0474-0006 | Supporting & Related Material | Background Material | 2015-02-19T05:00:00Z | 2015 | 2 | 2015-02-19T13:17:08Z | 0 | 0 | 0900006481a093dd | |||
| FDA-2008-N-0474-0003 | FDA | None FDA-2008-N-0474 | Time and Extent Application (TEA) from L'Oreal USA Products, Inc., and Reference 1 - TEA for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated September 18, 2007, Background Material Book 2 | Supporting & Related Material | Background Material | 2008-09-15T04:00:00Z | 2008 | 9 | 2015-02-18T19:45:14Z | 0 | 0 | 090000648070674b | |||
| FDA-2008-N-0474-0002 | FDA | None FDA-2008-N-0474 | Time and Extent Application (TEA) from L'Oreal USA Products, Inc., and Reference 1 - TEA for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated September 18, 2007, Background Material Book 1 | Supporting & Related Material | Background Material | 2008-09-15T04:00:00Z | 2008 | 9 | 2015-02-18T19:42:31Z | 0 | 0 | 0900006480706718 | |||
| FDA-2008-N-0474-0005 | FDA | None FDA-2008-N-0474 | Report/Review of Time and Extent Application (TEA) from FDA CDER for L'Oreal USA Products, Inc., TEA (Terephthalylidene Dicamphor Sufonic Acid) dated September 25, 2007 | Supporting & Related Material | Report | 2008-09-15T04:00:00Z | 2008 | 9 | 2015-02-18T19:48:57Z | 0 | 0 | 09000064807067a2 | |||
| FDA-2008-N-0474-0004 | FDA | None FDA-2008-N-0474 | Time and Extent Application (TEA) Amendment from L'Oreal USA Products, Inc., and Reference 1 - TEA for Ecamsule (Terephthalylidene Dicamphor Sufonic Acid) dated February 5, 2008 | Supporting & Related Material | Background Material | 2008-09-15T04:00:00Z | 2008 | 9 | 2015-02-18T19:46:06Z | 0 | 0 | 0900006480706777 | |||
| FDA-2008-N-0474-0001 | FDA | None FDA-2008-N-0474 | Ecamsule Eligibility for Inclusion in Monograph; Over-the-Counter Sunscreen Drug Products for Human Use; Request for Safety and Effectiveness Data | Notice | Requests for Information (RFI) | 2008-09-12T04:00:00Z | 2008 | 9 | 2008-09-12T04:00:00Z | 2008-12-12T04:59:59Z | 2015-02-20T03:01:32Z | E8-21291 | 0 | 0 | 09000064807017ef |
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CREATE TABLE documents (
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
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
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;