CARVEDILOL PHOSPHATE | N022012 | WAYLIS THERAPEUTICS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from AMTA Labs Limited FDA-2025-P-0101 · 4 docket documents AMTA Labs Limited submitted this citizen petition on January 9, 2025, requesting that the FDA Commissioner determine whether COREG CR (carvedilol phosphate) extended-release capsules in strengths of 10 mg, 20 mg, 40 mg, and 80 mg under NDA 022012 held by Waylis Therapeutics LLC was voluntarily withd | 505(q) | 2025-01-10 | Granted | AMTA Labs Limited |
Suitability Petition from Emprise Pharma LLC, on behalf of New Time Pharmaceu... FDA-2020-P-2166 · 8 docket documents Emprise Pharma LLC, on behalf of New Time Pharmaceutical Co., Ltd., submitted this suitability petition under section 512(n)(3) of the Federal Food, Drug, and Cosmetic Act requesting approval to file an ANDA for Carvedilol bilayered extended-release tablets using Coreg CR capsules as the reference l | Suitability | 2020-11-05 | Withdrawn | New Time Pharmaceutical Co, Ltd |
Flamel Technologies S.A. (Frommer Lawrence & Haug LLP) - Citizen Petition FDA-2010-P-0216 · 21 docket documents Flamel Technologies S.A., represented by Frommer Lawrence & Haug LLP, filed this citizen petition on April 19, 2010, pursuant to Sections 505(j) and 505(q) of the Federal Food, Drug, and Cosmetic Act, requesting that the FDA require all ANDAs and 505(b)(2) NDAs for generic formulations of Coreg CR ( | 505(q) | 2010-04-26 | Partially Denied | — |
Citizen Petition from Keller And Heckman LLP FDA-2007-P-0058 · 11 docket documents Keller and Heckman LLP filed this suitability petition under Section 505(j)(2)(C) requesting FDA approval to file an ANDA for carvedilol phosphate in extended-release tablet form, which would differ from the reference listed drug Coreg CR (carvedilol phosphate extended-release capsules) only in dosa | Other | 2008-07-10 | Withdrawn | Keller And Heckman LLP |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8101209 | Sep 11, 2025PED: Mar 11, 2026 | PED | — | Yes | — | — |