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 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 strengths of 2 mg, 3 mg, 4 mg, and 6 mg suitable for submission as an ANDA, wit | Suitability | 2026-06-16 | Open | Senores Pharmaceuticals, Inc. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-5978 · 7 docket documents The law firm Hyman, Phelps & McNamara, P.C. filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Cyproheptadine HCL Tablets in 3 mg and 6 mg strengths suitable for submission as an Abbreviated New Drug Application, referen | 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.