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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 089057


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NDA 089057 describes CYPROHEPTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Chartwell Molecular, Elysium, Halsey, Lyne, Morton Grove, Naska, Patrin, Pharm Assoc, Quagen, Tris Pharma Inc, Am Therap, Appco, Ascot, Beximco Pharms Usa, Chartwell Rx, Duramed Pharms Barr, Fosun Pharma, Heritage Pharma, Kenton, Kv Pharm, Md Pharm, Mountain, Mylan, Novast Labs, Pioneer Pharms, Pliva, Rising, Strides Pharma, Superpharm, Vitarine, Watson Labs, and Zydus Pharms, and is included in thirty-nine NDAs. It is available from twenty-three 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-three suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.
Summary for 089057
Tradename:CYPROHEPTADINE HYDROCHLORIDE
Applicant:Halsey
Ingredient:cyproheptadine hydrochloride
Patents:0
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength4MG
Approval Date:Jul 3, 1986TE:RLD:No

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