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Boehringer Ingelheim

Last Updated: April 10, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 086833

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NDA 086833 describes CYPROHEPTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Anda Repository, Elysium, Halsey, Lannett Co Inc, Lyne, Morton Grove, Naska, Pharm Assoc, Quagen, Am Therap, Apex Pharms Inc, Ascot, Beximco Pharms Usa, Boscogen, Chartwell Rx, Duramed Pharms Barr, Fosun Pharma, Heritage Pharma, Kv Pharm, Md Pharm, Mountain, Mylan, Novast Labs, Par Pharm, Pioneer Pharms, Pliva, Strides Pharma, Superpharm, Twi Pharms, Vitarine, Watson Labs, and Zydus Pharms, and is included in thirty-seven NDAs. It is available from twenty-six 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-six suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.
Summary for 086833
Applicant:Actavis Mid Atlantic
Ingredient:cyproheptadine hydrochloride
Formulation / Manufacturing:see details

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:SYRUP;ORALStrength2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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