LOPRESSOR

FDA-2025-P-2104

Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client under Section 505(j)(2)(C) of the FD&C Act, requesting that the FDA declare Metoprolol Tartrate Tablets, 12.5 mg suitable for submission as an ANDA based on the reference listed drug LOPRESSOR (metoprolol tartrat

FDA-2021-P-0124

Hyman, Phelps & McNamara, P.C. filed this withdrawal of a suitability petition originally submitted on January 25, 2021, and supplemented on May 6, 2022, requesting FDA's determination of whether Metoprolol Tartrate Tablets, 12.5 mg, was suitable for submission in an Abbreviated New Drug Application

FDA-2021-P-0124

On January 25, 2021, Hyman, Phelps & McNamara P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Metoprolol Tartrate Tablets, 12.5 mg, suitable for submission as an abbreviated new drug application (ANDA), with the

FDA-2002-P-0505

Lachman Consultant Services, Inc., filed this citizen petition on behalf of a client requesting that the FDA declare Metoprolol Tartrate Tablets USP, 25 mg suitable for consideration in an abbreviated new drug application (ANDA) under Section 505(j)(2)(C), with Lopressor (Metoprolol Tartrate) Tablet

FDA-2014-P-0647

Kamat Pharmatech filed this suitability petition pursuant to 21 CFR 314.93 and section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Metoprolol Tartrate Oral Solution (10 mg/mL) suitable for submission as an abbreviated new drug application (ANDA), with the

FDA-2003-P-0010

Nabeal M. Saif, R.Ph., filed this citizen petition pursuant to Section 505(j)(2)(c) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA determine metoprolol tartrate 12.5 mg tablets are suitable for consideration in an Abbreviated New Drug Application based on the listed drug Lopress

FDA-2006-P-0281

Kendle International filed this suitability petition pursuant to 21 U.S.C. § 355(j)(2)(C) and 21 C.F.R. § 10.30 and 314.93 requesting that the FDA determine that a 12.5 mg tablet of Metoprolol Tartrate is suitable for an Abbreviated New Drug Application or supplemental ANDA based on the reference li

FDA-2007-P-0409

Lachman Consultant Services, Inc. filed this citizen petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Metoprolol Tartrate Tablets USP in 37.5 mg and 75 mg strengths suitable for submission as an abbreviated new drug application, with the