INDERAL

FDA-2026-P-7228

Senores Pharmaceuticals, Inc. filed a suitability petition seeking FDA confirmation that the proposed drug substance and drug product specifications for their pharmaceutical formulation are appropriate for use in an abbreviated new drug application (ANDA) or new drug application (NDA) submission.

FDA-1985-P-0240

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

FDA-2023-P-4320

Lachman Consultant Services, Inc. filed a petition regarding the suitability of INDERAL (propranolol) tablets, as documented in the FDA Orange Book. The petition addresses regulatory considerations related to the approved drug product listing and its Orange Book designation.

FDA-2023-P-4320

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

FDA-2023-P-4320

Lachman Consultant Services, Inc. filed a petition regarding the prescribing information for INDERAL (propranolol) tablets, which appears to relate to the suitability or acceptability of the product's labeling and regulatory documentation. The specific requested action involves review and potential

FDA-2019-P-4515

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

FDA-1985-P-0019

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

FDA-1992-P-0493

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

FDA-2007-P-0233

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,