INDERAL

FDA-2026-P-7228

Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA declare Propranolol Hydrochloride Tablets in 120 mg and 160 mg strengths suitable for submission in an Abbreviated

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 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-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 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.