dockets: FDA-2021-P-0895

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-2021-P-0895 FDA Requesting that the FDA refuse to approve any, and withdraw approval of any approved but not yet marketed, ANDA or 505(b)(2) NDA that has vasopressin, 8-L-arginine as its active ingredient unless and until the applicant or sponsor take the following two actions described below Nonrulemaking 2021-12-29T08:27:34Z 0b00006484c4a4ef         ["OPEN", "reference listed drug (RLD)", "risk of the follow-on product\u2019s immunogenicity", "impurity profile", "peptide aggregation profile", "vasopressin, 8-L-arginine", "505(b)(2) New Drug Application (NDA)", "Abbreviated New Drug Application (ANDA)", "Eagle Pharmaceuticals", "CDER", "Citizen Petition"] CDER Requesting that the FDA refuse to approve any, and withdraw approval of any approved but not yet marketed, ANDA or 505(b)(2) NDA that has vasopressin, 8-L-arginine as its active ingredient unless and     {"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": ["OPEN", "reference listed drug (RLD)", "risk of the follow-on product\u2019s immunogenicity", "impurity profile", "peptide aggregation profile", "vasopressin, 8-L-arginine", "505(b)(2) New Drug Application (NDA)", "Abbreviated New Drug Application (ANDA)", "Eagle Pharmaceuticals", "CDER", "Citizen Petition"], "modifyDate": "2021-12-29T08:27:34Z", "dkAbstract": null, "agencyId": "FDA", "program": "CDER", "shortTitle": "Requesting that the FDA refuse to approve any, and withdraw approval of any approved but not yet marketed, ANDA or 505(b)(2) NDA that has vasopressin, 8-L-arginine as its active ingredient unless and ", "subType2": null, "title": "Requesting that the FDA refuse to approve any, and withdraw approval of any approved but not yet marketed, ANDA or 505(b)(2) NDA that has vasopressin, 8-L-arginine as its active ingredient unless and until the applicant or sponsor take the following two actions described below", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b00006484c4a4ef"} single_get

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