CARVEDILOL PHOSPHATE | N022012 | WAYLIS THERAPEUTICS LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from AMTA Labs Limited FDA-2025-P-0101 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 | Denied | AMTA Labs Limited |
Reference 2 Package insert for Coreg CR re Suitability Petition from Emprise ... FDA-2020-P-2166 Emprise Pharma LLC, on behalf of New Time Pharmaceutical Co, Ltd, filed a citizen petition requesting that the FDA determine the suitability of the Coreg CR package insert as a reference standard for an ANDA submission. The petition seeks FDA guidance on whether the existing Coreg CR labeling can be | Suitability | 2020-11-05 | Open | Emprise Pharma LLC |
Suitability Petition from Emprise Pharma LLC, on behalf of New Time Pharmaceu... FDA-2020-P-2166 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 | Open | Emprise Pharma LLC |
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 | — | — |