dockets: FDA-2003-P-0007

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-2003-P-0007 FDA determine whether Lexapro (escitalopram oxalate) tablets 5 mg (NDA 21-323, Product 001),manufactured by Forest laboratories, have been withdrawn or withheld from sale for safety or efficacy reasons Nonrulemaking 2021-09-01T01:02:52Z 0b000064804811ab   Docket Status: CLOSED     ["Product 001", "NDA 21-323", "escitalopram oxalate", "Lexapro", "CDER"] CDER Lexapro (escitalopram oxalate) tablets 5mg (NDA 21-323, Product 001),mfged by Forest Laboratories have been voluntarily withdrawn or withheld from sale for safety or efficacy reasons     {"displayProperties": [{"name": "abstract", "label": "General Information", "tooltip": "Describes an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": "shortTitle", "label": "Short Title", "tooltip": "A combination of letters and or numbers assigned to an agency's regulatory action for purposes of brevity."}], "keywords": ["Product 001", "NDA 21-323", "escitalopram oxalate", "Lexapro", "CDER"], "modifyDate": "2021-09-01T01:02:52Z", "dkAbstract": "Docket Status: CLOSED", "agencyId": "FDA", "program": "CDER", "shortTitle": "Lexapro (escitalopram oxalate) tablets 5mg (NDA 21-323, Product 001),mfged by Forest Laboratories have been voluntarily withdrawn or withheld from sale for safety or efficacy reasons", "subType2": null, "title": "determine whether Lexapro (escitalopram oxalate) tablets 5 mg (NDA 21-323, Product 001),manufactured by Forest laboratories, have been withdrawn or withheld from sale for safety or efficacy reasons", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": "2003P-0284", "subType": null, "category": null, "field2": null, "effectiveDate": null, "objectId": "0b000064804811ab"} single_get

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