CARVEDILOL PHOSPHATE | A090132 | SUN PHARMACEUTICAL INDUSTRIES INC
| 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.