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CYPROHEPTADINE HYDROCHLORIDE

ANDA

CYPROHEPTADINE HYDROCHLORIDE | A040668 | RISING PHARMA HOLDINGS INC

1 strength0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
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.

Source: Regulations.gov. FDA citizen petitions matched by application number.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$0.0411

per ml

Lowest NADAC/Unit

$0.0411

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
64980050448CYPROHEPTADINE 2 MG/5 ML SYRUP	$0.0411	ML	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

API Supply Chain1 active DMF1 inactive

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

OLON SPACYPROHEPTADINE HYDROCHLORIDE

DMF 32931978

CHANGZHOU SIYAO PHARMACEUTICALS CO LTDInactiveCYPROHEPTADINE HYDROCHLORIDE

DMF 173642004

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 13, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 2MG/5ML

0 patents0 exclusivities▴

SYRUP;ORAL | Approved: Jun 28, 2006

No patent or exclusivity listings for this strength.