dockets: FDA-2008-P-0591

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-2008-P-0591 FDA ANDA Suitablity Petition to Determine Whether a 1mg/mL (1mg/1mL, 3mg/3mL and 4mg/4mL) Topotecan Hydrochloride Injection Solution may be Filed as an Abbreviated New Drug Application - CLOSED Nonrulemaking 2022-01-05T01:03:30Z 0b000064807a5316         ["topotecan", "hycamtin", "hydrochloride", "20-671", "CDER", "CLOSED"] CDER Topotecan Hydrochloride Injection Solution may be Filed as an Abbreviated New Drug Application     {"displayProperties": [{"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": ["topotecan", "hycamtin", "hydrochloride", "20-671", "CDER", "CLOSED"], "modifyDate": "2022-01-05T01:03:30Z", "dkAbstract": null, "agencyId": "FDA", "program": "CDER", "shortTitle": "Topotecan Hydrochloride Injection Solution may be Filed as an Abbreviated New Drug Application", "subType2": null, "title": "ANDA Suitablity Petition to Determine Whether a 1mg/mL (1mg/1mL, 3mg/3mL and 4mg/4mL) Topotecan Hydrochloride Injection Solution may be Filed as an Abbreviated New Drug Application - CLOSED", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "CLOSED", "effectiveDate": null, "objectId": "0b000064807a5316"} single_get

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