dockets: FDA-2012-P-0661

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-0661 FDA Issue a Written Decision Holding That the Sponsor Entitled to 180-day Exclusivity Rights in Connection With Generic Version of NEXIUM Esomeprazole Magnesium Delayed Release Capsules 20mg and 40mg has Forfeited Those Rights for Failure to Obtain Tentative Approval Within 30 Months of Submission of its Abbreviated New Drug Application ANDA Nonrulemaking 2015-04-14T11:58:10Z 0b0000648105c61a   Closed Petition Denied 1/26/2015     ["cder", "NEXIUM", "esomeprazole magnesium", "20mg", "40mg", "180-day exclusivity"] CDER Issue a Written Decision Holding That the Sponsor Entitled to 180-day Exclusivity Rights in Connection With Generic Version of NEXIUM Esomeprazole Magnesium Delayed Release Capsules 20mg and 40mg     {"displayProperties": [{"name": "abstract", "label": "General Information", "tooltip": "Describes an agency's specific regulatory action; equivalents: Abstract, Description, Docket Subject, Related To, Summary."}, {"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", "NEXIUM", "esomeprazole magnesium", "20mg", "40mg", "180-day exclusivity"], "modifyDate": "2015-04-14T11:58:10Z", "dkAbstract": "Closed Petition Denied 1/26/2015", "agencyId": "FDA", "program": "CDER", "shortTitle": "Issue a Written Decision Holding That the Sponsor Entitled to 180-day Exclusivity Rights in Connection With Generic Version of NEXIUM Esomeprazole Magnesium Delayed Release Capsules 20mg and 40mg", "subType2": null, "title": "Issue a Written Decision Holding That the Sponsor Entitled to 180-day Exclusivity Rights in Connection With Generic Version of NEXIUM Esomeprazole Magnesium Delayed Release Capsules 20mg and 40mg has Forfeited Those Rights for Failure to Obtain Tentative Approval Within 30 Months of Submission of its Abbreviated New Drug Application ANDA", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": "2012-5268", "subType": null, "category": null, "field2": "Closed", "effectiveDate": null, "objectId": "0b0000648105c61a"} single_get

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