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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

7 rows where docket_id = "FDA-2017-P-7034" sorted by posted_date descending

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

posted_year 2

  • 2017 6
  • 2025 1

document_type 2

  • Supporting & Related Material 4
  • Other 3

agency_id 1

  • FDA 7
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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2017-P-7034-0007 FDA None FDA-2017-P-7034 Response Letter from FDA CDER to Jubilant Generics Limited Other Letter(s) 2025-07-31T04:00:00Z 2025 7 2025-07-31T04:00:00Z   2025-07-31T18:24:31Z   0 0 09000064b8ebc5b5
FDA-2017-P-7034-0003 FDA None FDA-2017-P-7034 Exhibit 1 Orange Book Listing re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:53:20Z   0 0 0900006482d84d72
FDA-2017-P-7034-0005 FDA None FDA-2017-P-7034 Exhibit 3 Proposed Product Draft Label re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:53:46Z   0 0 0900006482d84d74
FDA-2017-P-7034-0001 FDA None FDA-2017-P-7034 Citizen Petition from Jubilant Generics Limited Other Citizen Petition 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z 2018-06-28T03:59:59Z 2018-01-02T16:52:40Z   0 0 0900006482d84d2a
FDA-2017-P-7034-0006 FDA None FDA-2017-P-7034 Exhibit 4 Valtrex Tablets 250 mg re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:53:57Z   0 0 0900006482d84d75
FDA-2017-P-7034-0004 FDA None FDA-2017-P-7034 Exhibit 2 RLD Label re Citizen Petition from Jubilant Generics Limited Supporting & Related Material Background Material 2017-12-29T05:00:00Z 2017 12     2018-01-02T16:53:34Z   0 0 0900006482d84d73
FDA-2017-P-7034-0002 FDA None FDA-2017-P-7034 Acknowledgment Letter from FDA DDM to Jubilant Generics Limited Other Acknowledgement Letter/Receipt 2017-12-29T05:00:00Z 2017 12 2017-12-29T05:00:00Z   2018-01-02T16:53:05Z   0 0 0900006482d84d2c

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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;
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