INDOMETHACIN | A091276 | GLENMARK PHARMACEUTICALS LTD
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Rising Pharma Holdings, Inc. FDA-2025-P-1164 Rising Pharma Holdings, Inc. submitted this suitability petition under section 502(j)(2)(C) of the FDC Act requesting a declaration that an Abbreviated New Drug Application may be submitted for Indomethacin Capsules USP in 18.75 mg and 37.5 mg strengths, which differ from the reference listed drug I | Suitability | 2025-05-09 | Open | Rising Pharma Holdings |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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