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

6 rows where docket_id = "FDA-2021-P-0567" sorted by posted_date descending

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Suggested facets: subtype, posted_date, posted_month, comment_start_date, open_for_comment, posted_date (date), comment_start_date (date), last_modified (date)

posted_year 2

document_type 2

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2021-P-0567-0006 FDA Requests that the FDA declare that the drug product, Solifenacin Oral Solution, 1 mg/mL is suitable for submission in an Abbreviated New Drug Application FDA-2021-P-0567 Response Letter Other Letter(s) 2026-06-10T04:00:00Z 2026 6 2026-06-10T04:00:00Z   2026-06-10T22:15:38Z   0 0 09000064b931e217
FDA-2021-P-0567-0002 FDA Requests that the FDA declare that the drug product, Solifenacin Oral Solution, 1 mg/mL is suitable for submission in an Abbreviated New Drug Application FDA-2021-P-0567 Acknowledgement Letter from FDA DMS to M A Pharmaceutical Consulting Inc Other Acknowledgement Letter/Receipt 2021-07-07T04:00:00Z 2021 7 2021-07-07T04:00:00Z   2021-07-07T19:39:12Z   0 0 0900006484b9b4be
FDA-2021-P-0567-0001 FDA Requests that the FDA declare that the drug product, Solifenacin Oral Solution, 1 mg/mL is suitable for submission in an Abbreviated New Drug Application FDA-2021-P-0567 Suitability Petition from M A Pharmaceutical Consulting Inc Other Petition(s) 2021-07-07T04:00:00Z 2021 7 2021-07-07T04:00:00Z   2024-11-12T23:31:51Z   1 0 0900006484b9b462
FDA-2021-P-0567-0003 FDA Requests that the FDA declare that the drug product, Solifenacin Oral Solution, 1 mg/mL is suitable for submission in an Abbreviated New Drug Application FDA-2021-P-0567 Attachment 1 Approved Drug Products with Therapeutic Equivalence Evaluations re Suitability Petition from M A Pharmaceutical Consulting Inc Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T19:39:24Z   0 0 0900006484ba0eba
FDA-2021-P-0567-0004 FDA Requests that the FDA declare that the drug product, Solifenacin Oral Solution, 1 mg/mL is suitable for submission in an Abbreviated New Drug Application FDA-2021-P-0567 Attachment 2 Vesicare LS Solifenacin Succinate Oral Suspension re Suitability Petition from M A Pharmaceutical Consulting Inc Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T19:39:29Z   0 0 0900006484ba0f31
FDA-2021-P-0567-0005 FDA Requests that the FDA declare that the drug product, Solifenacin Oral Solution, 1 mg/mL is suitable for submission in an Abbreviated New Drug Application FDA-2021-P-0567 Attachment 3 Proposed label for Solifenacin Succinate Oral Solution re Suitability Petition from M A Pharmaceutical Consulting Inc Supporting & Related Material Background Material 2021-07-07T04:00:00Z 2021 7     2021-07-07T19:39:34Z   0 0 0900006484ba0f32

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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;