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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 087001

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NDA 087001 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, 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-one 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-one suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.

Summary for 087001

Tradename:	CYPROHEPTADINE HYDROCHLORIDE
Applicant:	Morton Grove
Ingredient:	cyproheptadine hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 087001

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:	Nov 4, 1982	TE:		RLD:	No

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