INDOMETHACIN | A073314 | COSETTE PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Zydus Pharmaceuticals (USA) Inc FDA-2023-P-4360 Zydus Pharmaceuticals (USA) Inc. filed this citizen petition under 21 C.F.R. § 10.25 et seq. requesting that the FDA investigate and take prompt enforcement action against Wells Pharma's unapproved Indomethacin suppository 100 mg product, which is not included in the FDA's 503(B) outsourcing facilit | 505(q) | 2023-10-06 | Denied | Zydus Pharmaceuticals (USA) Inc |
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. on behalf of Zydus Li... FDA-2023-P-3944 Zydus Pharmaceuticals (USA) Inc., on behalf of Zydus Lifesciences Ltd., filed this citizen petition on September 14, 2023, requesting that the FDA ensure the currently marketed Indocin Suppositories USP 50 mg approved under ANDA 073314 complies with ICH guidelines and established impurity acceptance | 505(q) | 2023-09-14 | Denied | Zydus Pharmaceuticals (USA) Inc. on behalf of Zydus Lifesciences Ltd |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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