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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 204823

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NDA 204823 describes CYPROHEPTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Chartwell Molecular, Halsey, Invatech, Morton Grove, Naska, Patrin, Pharm Assoc, Quagen, Rising, Tris Pharma Inc, Am Therap, Appco, Ascot, Chartwell Rx, Duramed Pharms Barr, Heritage Pharma, Kenton, Kv Pharm, Md Pharm, Mountain, Mylan, Novast Labs, Pioneer Pharms, Pliva, Regcon Holdings, Strides Pharma Intl, Superpharm, Vitarine, Watson Labs, and Zydus Pharms, and is included in thirty-nine NDAs. It is available from twenty-two suppliers. Additional details are available on the CYPROHEPTADINE HYDROCHLORIDE profile page.

The generic ingredient in CYPROHEPTADINE HYDROCHLORIDE is cyproheptadine hydrochloride. There are six drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.

Summary for 204823

Tradename:	CYPROHEPTADINE HYDROCHLORIDE
Applicant:	Patrin
Ingredient:	cyproheptadine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 204823

Anti-Allergic Agents
Antipruritics
Gastrointestinal Agents
Histamine H1 Antagonists
Serotonin Antagonists

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SYRUP;ORAL			Strength	2MG/5ML
Approval Date:	Dec 27, 2016	TE:		RLD:	No

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