METOPROLOL TARTRATE | N018704 | NOVARTIS PHARMACEUTICALS CORP
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Withdraws the Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2021-P-0124 · 8 docket documents 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Tablets, 12.5 mg, was suitable for submission in an Abbreviated New Drug Application | Suitability | 2023-08-14 | Withdrawn | Hyman, Phelps & McNamara, P.C. |
Citizen Petition from Lachman Consultant Services Inc. FDA-2002-P-0505 · 6 docket documents 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 | Other | 2018-12-04 | Granted | Lachman Consultant Services Inc. |
Citizen Petition From Kamat Pharmatech FDA-2014-P-0647 · 5 docket documents 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(10 mg/mL) suitable for submission as an abbreviated new drug application (ANDA), with the | Other | 2014-05-22 | Withdrawn | Kamat Pharmatech |
Citizens Petition from Nabeal M. Saif, R.Ph. FDA-2003-P-0010 · 5 docket documents 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 | Other | 2009-01-22 | Denied | Nabeal M. Saif, R.Ph. |
Citizen Petition from Kendle International FDA-2006-P-0281 · 7 docket documents 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suitable for an Abbreviated New Drug Application or supplemental ANDA based on the reference li | Other | 2008-08-21 | Withdrawn | Kendle International |
Citizen Petition from Lachman Consultant Services, Inc. FDA-2007-P-0409 · 7 docket documents 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 | Other | 2008-06-13 | Granted | Lachman Consultant Services, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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