METOPROLOL TARTRATE | N017963 | VALIDUS PHARMACEUTICALS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2025-P-2104 · 8 docket documents 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 | Suitability | 2025-07-03 | Denied | Lachman Consulting Services, Inc. |
Suitability Petition from Hyman, Phelps & McNamara P.C. FDA-2021-P-0124 · 8 docket documents 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12.5 mg, suitable for submission as an abbreviated new drug application (ANDA), with the | Suitability | 2021-01-28 | Withdrawn | Hyman, Phelps & McNamara P.C. |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(10 mg/mL) suitable for submission as an abbreviated new drug application (ANDA), with the | Other | 2014-05-22 | Withdrawn | Kamat Pharmatech |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.
Highest NADAC/Unit
$2.42
per ea
Lowest NADAC/Unit
$2.42
per ea
Brand NDCs
1
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 30698045801LOPRESSOR 50 MG TABLET | $2.42 | EA | Brand | $0.0189 | 2026-01-21 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.