dockets: FDA-2025-P-7056

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

This data as json

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-2025-P-7056 FDA Requests that FDA declare that Labetalol Hydrochloride Tablets, 50 mg and 150 mg, are suitable for submission as an ANDA Nonrulemaking 2025-12-31T17:05:28Z 0b000064b90d45bf   Open     ["CDER", "Suitability Petition", "Hyman, Phelps & McNamara, P.C.", "Requests that FDA declare that", "Labetalol Hydrochloride Tablets,", "50 mg and 150 mg, are suitable for", "submission as an ANDA", "the Reference Listed Drug (\u201cRLD\u201d) upon which", "this petition is based is", "Schering Corp\u2019s NORMODYNE", "(labetalol hydrochloride) Tablets,", "which is approved for prescription use under", "New Drug Application (NDA) 018687 in", "100 mg, 200 mg, 300 mg, and 400 mg strength", "Open"] CDER Requests that FDA declare that Labetalol Hydrochloride Tablets, 50 mg and 150 mg, are suitable for submission as an ANDA     {"displayProperties": [{"name": "abstract", "label": "General Information", "tooltip": "Describes an agency's specific regulatory action; equivalents: Abstract, Description, Docket Subject, Related To, Summary."}, {"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", "Suitability Petition", "Hyman, Phelps & McNamara, P.C.", "Requests that FDA declare that", "Labetalol Hydrochloride Tablets,", "50 mg and 150 mg, are suitable for", "submission as an ANDA", "the Reference Listed Drug (\u201cRLD\u201d) upon which", "this petition is based is", "Schering Corp\u2019s NORMODYNE", "(labetalol hydrochloride) Tablets,", "which is approved for prescription use under", "New Drug Application (NDA) 018687 in", "100 mg, 200 mg, 300 mg, and 400 mg strength", "Open"], "modifyDate": "2025-12-31T17:05:28Z", "dkAbstract": "Open", "agencyId": "FDA", "program": "CDER", "shortTitle": "Requests that FDA declare that Labetalol Hydrochloride Tablets, 50 mg and 150 mg, are suitable for submission as an ANDA", "subType2": null, "title": "Requests that FDA declare that Labetalol Hydrochloride Tablets, 50 mg and 150 mg, are suitable for submission as an ANDA", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b000064b90d45bf"} single_get

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