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

12 rows where docket_id = "FDA-2005-P-0194" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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-2005-P-0194-0015 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Attachment 11 Package Insert on KEPPRA re Citizen Petition from Warren Rucker Supporting & Related Material Reference (external attachments) 2018-06-27T04:00:00Z 2018 6     2018-06-27T17:06:00Z   0 0 0900006480440ebb
FDA-2005-P-0194-0008 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Attachment 4 Prescription Order for Warren Rucker re Citizen Petition from Warren Rucker Supporting & Related Material Reference (external attachments) 2018-06-27T04:00:00Z 2018 6     2018-06-27T16:24:52Z   0 0 0900006480440eb4
FDA-2005-P-0194-0013 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Attachment 9 Serious Side Effects of KEPPRA re Citizen Petition from Warren Rucker Supporting & Related Material Reference (external attachments) 2018-06-27T04:00:00Z 2018 6     2018-06-27T16:54:39Z   0 0 0900006480440eb9
FDA-2005-P-0194-0004 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Citizen Petition from Warren Rucker Other Citizen Petition 2018-06-27T04:00:00Z 2018 6 2005-12-30T05:00:00Z   2018-08-13T15:56:57Z   0 0 0900006480440eaf
FDA-2005-P-0194-0009 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Attachment 5 KEPPRA Side Effects, Drug Interactions re Citizen Petition from Warren Rucker Supporting & Related Material Reference (external attachments) 2018-06-27T04:00:00Z 2018 6     2018-08-13T15:59:23Z   0 0 0900006480440eb5
FDA-2005-P-0194-0011 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Attachment 7 Canada Pharmacy Drug Information on KEPPRA re Citizen Petition from Warren Rucker Supporting & Related Material Reference (external attachments) 2018-06-27T04:00:00Z 2018 6     2018-08-13T16:00:47Z   0 0 0900006480440eb7
FDA-2005-P-0194-0006 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Attachment 2 Letter from UCB Pharma, Inc. to Warren Rucker re Citizen Petition from Warren Rucker Supporting & Related Material Reference (external attachments) 2018-06-27T04:00:00Z 2018 6     2018-06-27T16:12:38Z   0 0 0900006480440eb2
FDA-2005-P-0194-0012 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Attachment 8 How KEPPRA May Affect You re Citizen Petition from Warren Rucker Supporting & Related Material Reference (external attachments) 2018-06-27T04:00:00Z 2018 6     2018-08-13T16:01:38Z   0 0 0900006480440eb8
FDA-2005-P-0194-0010 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Attachment 6 Columbia Epilepsy's Listing of KEPPRA Side Effects re Citizen Petition from Warren Rucker Supporting & Related Material Reference (external attachments) 2018-06-27T04:00:00Z 2018 6     2018-08-13T16:00:16Z   0 0 0900006480440eb6
FDA-2005-P-0194-0003 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Response letter from FDA Warren Rucker Other Letter(s) 2017-07-27T04:00:00Z 2017 7 2017-07-27T04:00:00Z   2017-07-27T18:33:58Z   0 0 090000648297a33d
FDA-2005-P-0194-0002 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Interim Response Letter from FDA CDER to Warren Rucker Other Letter(s) 2006-06-28T04:00:00Z 2006 6     2018-06-27T15:46:06Z   0 0 0900006480440ebe
FDA-2005-P-0194-0001 FDA Evaluation of the Adequacy of Warnings to Patient-Consumers that Psychosis Is a Possible Adverse effect of Keppra (levetiracetam) - CLOSED FDA-2005-P-0194 Acknowledgment Letter from FDA DDM to Warren Rucker Other Acknowledgement Letter/Receipt 2005-12-30T05:00:00Z 2005 12     2018-08-13T15:51:37Z   0 0 0900006480440eae

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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);