CYPROHEPTADINE HYDROCHLORIDE | A040668 | RISING PHARMA HOLDINGS INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Amendment to Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1278 Senores Pharmaceuticals, Inc. filed an amendment to an ANDA suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to develop Cyproheptadine Hydrochloride orally disintegrating tablets in 2 mg and 4 mg strengths, based on the reference lis | Suitability | 2025-12-09 | Open | Senores Pharmaceuticals |
Amendment to Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1278 Senores Pharmaceuticals, Inc. filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Cyproheptadine Hydrochloride Orally Disintegrating Tablets in 2 mg and 4 mg strengths suitable for submission as an ANDA, with a reference li | Suitability | 2025-06-11 | Open | Senores Pharmaceuticals |
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1278 Senores Pharmaceuticals, Inc. filed this petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Cyproheptadine Hydrochloride Orally Disintegrating Tablets in 2 mg and 4 mg strengths suitable for submission as an ANDA, with the reference | Suitability | 2025-05-16 | Open | Senores Pharmaceuticals |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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