dockets: FDA-2012-P-1267

Regulatory dockets from Regulations.gov — containers for related documents and comments in a rulemaking proceeding.

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id agency_id title docket_type last_modified object_id rin dkabstract category subtype keywords program short_title effective_date organization attrs_raw attr_source
FDA-2012-P-1267 FDA Request Permission to File an Abbreviated New Drug Application (ANDA) Proposed Drug Product (Aspirin, Hydrocodone Bitartrate Tablets, 325 mg/ 5 mg) Suitable as the Current ANDA A089-420 Held by UCB Pharmaceuticals, Formerly Schwarz Pharma, Azdone™ (Aspirin, Hydrocodone Bitartrate Tablets, 500 mg/ 5 mg) - Citizen Petition, CLOSED: 7/9/2103 Nonrulemaking 2013-07-30T16:21:44Z 0b0000648119e6fb         ["cder", "2012-10199", "xspire pharma", "suitability petition", "ANDA A089-420", "Azdone", "aspirin", "hydrocodone bitartrate", "Aspradone", "anda", "325 mg/ 5 mg", "controlled substance", "STAGESICTM", "tablets", "open", "close"] CDER Request to File an ANDA having a different strength (Aspirin, Hydrocodone Bitartrate Tablets, 325 mg/ 5 mg) as the Current ANDA A089-420, CLOSED: 7/9/2103     {"displayProperties": [{"name": "legacyId", "label": "Legacy ID", "tooltip": "A pre-FDMS agency specific identifier migrated from a legacy system."}, {"name": "generic", "label": "Docket Item Code", "tooltip": "An agency specific code that identifies the type of document that established the docket (regulatory action)."}, {"name": "program", "label": "Center", "tooltip": "The agency specific program associated with the docket (regulatory action); equivalents: Docket Item Code, Location."}, {"name": "field2", "label": "Docket Status", "tooltip": "Used to Identity that a Docket's Status is Open or Closed"}, {"name": "shortTitle", "label": "Short Title", "tooltip": "A combination of letters and or numbers assigned to an agency's regulatory action for purposes of brevity."}], "keywords": ["cder", "2012-10199", "xspire pharma", "suitability petition", "ANDA A089-420", "Azdone", "aspirin", "hydrocodone bitartrate", "Aspradone", "anda", "325 mg/ 5 mg", "controlled substance", "STAGESICTM", "tablets", "open", "close"], "modifyDate": "2013-07-30T16:21:44Z", "dkAbstract": null, "agencyId": "FDA", "program": "CDER", "shortTitle": "Request to File an ANDA having a different strength (Aspirin, Hydrocodone Bitartrate Tablets, 325 mg/ 5 mg) as the Current ANDA A089-420, CLOSED: 7/9/2103", "subType2": null, "title": "Request Permission to File an Abbreviated New Drug Application (ANDA) Proposed Drug Product (Aspirin, Hydrocodone Bitartrate Tablets, 325 mg/ 5 mg) Suitable as the Current ANDA A089-420 Held by UCB Pharmaceuticals, Formerly Schwarz Pharma, Azdone\u2122 (Aspirin, Hydrocodone Bitartrate Tablets, 500 mg/ 5 mg) - Citizen Petition, CLOSED: 7/9/2103", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": "2012-10199", "subType": null, "category": null, "field2": "CLOSED", "effectiveDate": null, "objectId": "0b0000648119e6fb"} single_get

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