CYPROHEPTADINE HYDROCHLORIDE | A208938 | ZYDUS PHARMACEUTICALS USA INC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2026-P-6811 · 6 docket documents Senores Pharmaceuticals, Inc. filed this suitability petition pursuant to Section 505(j)(2)(C) requesting that the FDA declare Cyproheptadine Hydrochloride Orally Disintegrating Tablets in 2 mg, 3 mg, 4 mg, and 6 mg strengths suitable for submission as an ANDA, with the reference listed drug being P | Suitability | 2026-06-16 | Open | Senores Pharmaceuticals, Inc. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5978 · 7 docket documents Hyman, Phelps & McNamara, P.C. filed this suitability petition on behalf of a client under FDC Act Section 505(j)(2)(C) requesting that the FDA declare Cyproheptadine HCL Tablets in 3 mg and 6 mg strengths suitable for submission as an ANDA, with Merck's PERIACTIN (cyproheptadine HCL) Tablets 4 mg ( | Suitability | 2026-05-27 | Open | Hyman, Phelps & McNamara, P.C. |
Suitability Petition from Senores Pharmaceuticals, Inc. FDA-2025-P-1278 · 14 docket documents 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 | Granted | Senores Pharmaceuticals, Inc. |
Suitability Petition from Pharmobedient Consulting, LLC FDA-2024-P-4601 · 8 docket documents Pharmobedient Consulting, LLC filed a suitability petition pursuant to section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to submit an Abbreviated New Drug Application for Cyproheptadine Hydrochloride Tablets in 2 mg strength, which differs from the Reference Li | Suitability | 2024-10-01 | Granted | Pharmobedient Consulting, LLC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$0.0662
per ea
Lowest NADAC/Unit
$0.0662
per ea
Brand NDCs
0
Generic NDCs
2
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 70710111000CYPROHEPTADINE 4 MG TABLET | $0.0662 | EA | Generic | — | 2026-06-17 |
| 70710111001CYPROHEPTADINE 4 MG TABLET | $0.0662 | EA | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.