INDOMETHACIN | A073314 | COSETTE PHARMACEUTICALS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Zydus Pharmaceuticals (USA) Inc FDA-2023-P-4360 · 3 docket documents 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 | Open | Zydus Pharmaceuticals (USA) Inc |
Citizen Petition from Zydus Pharmaceuticals (USA) Inc. on behalf of Zydus Li... FDA-2023-P-3944 · 7 docket documents 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 Lifesciences Ltd |
Citizen Petition from Chem IQ FZCO FDA-2022-P-1667 · 3 docket documents Chem IQ FZCO filed this citizen petition requesting that the FDA ensure the currently marketed Indomethacin Suppositories 50 mg approved under ANDA 073314 complies with ICH guidelines and established impurity acceptance criteria, and refrain from approving future ANDAs that justify higher impurity l | 505(q) | 2022-07-25 | Denied | Chem IQ FZCO |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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