documents

Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

8 rows where docket_id = "FDA-2003-P-0015" sorted by posted_date descending

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posted_year 3

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agency_id 1

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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2003-P-0015-0006 FDA Make A Determination that the Galderma Product, Solage Containing 2% Mequinol, and 0.01% Tretinoin, NDA 20-922 Can Be Formulated As A Topical Solution with the Substitution of Hydroquinone at 4% for the 2% Mequinol and Fled as an ANDA Referencing Solage, NDA 20-922 as the Reference Listed Drug-CLOSED FDA-2003-P-0015 Citizens Petition from Jerussi Consulting, Inc. Other CP-Citizen Petition 2009-04-10T04:00:00Z 2009 4 2009-04-10T04:00:00Z   2024-11-04T19:26:24Z   0 0 090000648048132f
FDA-2003-P-0015-0010 FDA Make A Determination that the Galderma Product, Solage Containing 2% Mequinol, and 0.01% Tretinoin, NDA 20-922 Can Be Formulated As A Topical Solution with the Substitution of Hydroquinone at 4% for the 2% Mequinol and Fled as an ANDA Referencing Solage, NDA 20-922 as the Reference Listed Drug-CLOSED FDA-2003-P-0015 Letter from Jerussi Consulting, Inc. Other LET-Letter 2009-04-10T04:00:00Z 2009 4 2009-04-10T04:00:00Z   2024-11-04T19:39:26Z   0 0 0900006480481345
FDA-2003-P-0015-0007 FDA Make A Determination that the Galderma Product, Solage Containing 2% Mequinol, and 0.01% Tretinoin, NDA 20-922 Can Be Formulated As A Topical Solution with the Substitution of Hydroquinone at 4% for the 2% Mequinol and Fled as an ANDA Referencing Solage, NDA 20-922 as the Reference Listed Drug-CLOSED FDA-2003-P-0015 Letter from Jerussi Consulting, Inc. Other LET-Letter 2009-04-10T04:00:00Z 2009 4 2009-04-10T04:00:00Z   2024-11-04T19:35:24Z   0 0 0900006480481343
FDA-2003-P-0015-0005 FDA Make A Determination that the Galderma Product, Solage Containing 2% Mequinol, and 0.01% Tretinoin, NDA 20-922 Can Be Formulated As A Topical Solution with the Substitution of Hydroquinone at 4% for the 2% Mequinol and Fled as an ANDA Referencing Solage, NDA 20-922 as the Reference Listed Drug-CLOSED FDA-2003-P-0015 Petition Denial from FDA CDER to Jerussi Consulting, Inc. Other PDN-Petition Denial 2004-12-06T05:00:00Z 2004 12 2004-12-02T05:00:00Z   2024-11-04T19:28:37Z   0 0 0900006480481346
FDA-2003-P-0015-0004 FDA Make A Determination that the Galderma Product, Solage Containing 2% Mequinol, and 0.01% Tretinoin, NDA 20-922 Can Be Formulated As A Topical Solution with the Substitution of Hydroquinone at 4% for the 2% Mequinol and Fled as an ANDA Referencing Solage, NDA 20-922 as the Reference Listed Drug-CLOSED FDA-2003-P-0015 Petition Denial from FDA CDER to Jerussi Consulting, Inc. Other PDN-Petition Denial 2004-10-19T04:00:00Z 2004 10 2004-02-15T05:00:00Z   2024-11-04T19:28:23Z   0 0 0900006480481344
FDA-2003-P-0015-0003 FDA Make A Determination that the Galderma Product, Solage Containing 2% Mequinol, and 0.01% Tretinoin, NDA 20-922 Can Be Formulated As A Topical Solution with the Substitution of Hydroquinone at 4% for the 2% Mequinol and Fled as an ANDA Referencing Solage, NDA 20-922 as the Reference Listed Drug-CLOSED FDA-2003-P-0015 Letter from FDA CDER to Jerussi Consulting, Inc. Other LET-Letter 2004-02-05T05:00:00Z 2004 2 2004-02-03T05:00:00Z   2024-11-04T19:28:11Z   0 0 0900006480481342
FDA-2003-P-0015-0001 FDA Make A Determination that the Galderma Product, Solage Containing 2% Mequinol, and 0.01% Tretinoin, NDA 20-922 Can Be Formulated As A Topical Solution with the Substitution of Hydroquinone at 4% for the 2% Mequinol and Fled as an ANDA Referencing Solage, NDA 20-922 as the Reference Listed Drug-CLOSED FDA-2003-P-0015 Acknowledgement Letter from FDA DMB to Jerussi Consulting, Inc. Other Acknowledgement Letter/Receipt 2003-08-13T04:00:00Z 2003 8 2003-08-15T04:00:00Z   2024-11-04T19:02:42Z   0 0 090000648048132b
FDA-2003-P-0015-0002 FDA Make A Determination that the Galderma Product, Solage Containing 2% Mequinol, and 0.01% Tretinoin, NDA 20-922 Can Be Formulated As A Topical Solution with the Substitution of Hydroquinone at 4% for the 2% Mequinol and Fled as an ANDA Referencing Solage, NDA 20-922 as the Reference Listed Drug-CLOSED FDA-2003-P-0015 Acknowledgement Letter from FDA DMB to Jerussi Consulting, Inc. Other Acknowledgement Letter/Receipt 2003-08-13T04:00:00Z 2003 8     2024-10-08T13:59:54Z   0 0 090000648048133e

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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);