PROPRANOLOL HYDROCHLORIDE | N016418 | WYETH PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc FDA-2026-P-7228 · 5 docket documents Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Propranolol Hydrochloride Tablets in 120 mg and 160 mg strengths suitable for submission in an ANDA, with the reference listed dr | Suitability | 2026-06-29 | Open | Senores Pharmaceuticals, Inc |
Citizen Petition from ROXANE LABORATORIES, INC FDA-1985-P-0240 · 3 docket documents Roxane Laboratories, Inc. submitted this petition under Section 314.110(f) of the Food, Drug and Cosmetic Act requesting that the FDA determine ANDA suitability for Propranolol Hydrochloride Oral Solution, 20 mg per 5 ml, arguing that the product offers a valuable alternative dosage form to existing | Other | 2023-10-18 | Granted | ROXANE LABORATORIES, INC |
Suitability Petition from Lachman Consultant Services, Inc. FDA-2023-P-4320 · 8 docket documents Lachman Consultant Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Propranolol Orally Disintegrating Tablets in strengths of 10 mg, 20 mg, 40 mg, 60 mg, 80 mg, and 90 mg suitable for submission in a | Suitability | 2023-10-03 | Denied | Lachman Consultant Services, Inc. |
Citizen Petition from Foley & Lardner LLP FDA-2019-P-4515 · 5 docket documents Foley & Lardner LLP filed this citizen petition pursuant to Section 505(j) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA designate Propranolol Hydrochloride Tablets USP 80 mg held by Watson Laboratories Inc. (ANDA No. 070178) as an additional reference standard for ANDA submiss | 505(q) | 2019-09-26 | Open | Foley & Lardner LLP |
Verex Laboratories Inc. - Citizen Petition FDA-1985-P-0019 · 5 docket documents Verex Laboratories, Inc. filed this citizen petition under 21 CFR 10.30 and Section 314.2(c)(d) on March 20, 1985, requesting that the FDA Commissioner find an Abbreviated New Drug Application suitable for propranolol HCl 160 mg constant-release-rate tablets marketed as PROBLOK, a tablet formulation | Other | 2012-09-06 | Granted | — |
Citizen Petition from Flemington Pharmaceutical Corporation FDA-1992-P-0493 · 5 docket documents Flemington Pharmaceutical Corporation filed this citizen petition under section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act and 21 CFR 314.55(d) requesting permission to file an Abbreviated New Drug Application for effervescent propranolol hydrochloride tablets 40 mg, which differs from | Other | 2008-10-15 | Withdrawn | Flemington Pharmaceutical Corporation |
Regulus Pharmaceutical Consulting, Inc. - Citizen Petition FDA-2007-P-0233 · 7 docket documents Regulus Pharmaceutical Consulting, Inc. filed this citizen petition on behalf of a client requesting that the FDA determine whether Inderal (Propranolol Hydrochloride Tablets, 10 mg and 20 mg, NDA 016418) held by Wyeth Pharmaceuticals was discontinued for safety or effectiveness reasons, and if not, | 505(q) | 2008-05-10 | Open | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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