Last Updated: May 3, 2026

Details for New Drug Application (NDA): 088205

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NDA 088205 describes CYPROHEPTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Chartwell Molecular, Halsey, Morton Grove, Naska, Patrin, Pharm Assoc, Quagen, Rising, St John Pharm, Tris Pharma Inc, Am Therap, Anvi, Appco, Ascot, Chartwell Rx, Duramed Pharms Barr, Heritage Pharma, Ingenus Pharms Llc, Kenton, Kv Pharm, Md Pharm, Mountain, Mylan, 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 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 suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.

Summary for 088205

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

Medical Subject Heading (MeSH) Categories for 088205

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

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	4MG
Approval Date:	Jul 26, 1983	TE:		RLD:	No

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