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, Chartwell Molecular, Elysium, Halsey, Morton Grove, Naska, Patrin, Pharm Assoc, Quagen, Rising, Tris Pharma Inc, Am Therap, Appco, Ascot, Beximco Pharms Usa, Chartwell Rx, Duramed Pharms Barr, Heritage Pharma, Kenton, Kv Pharm, Md Pharm, Mountain, Mylan, Novast Labs, Pioneer Pharms, Pliva, 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.
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 086833
| Tradename: | CYPROHEPTADINE HYDROCHLORIDE |
| Applicant: | Actavis Mid Atlantic |
| Ingredient: | cyproheptadine hydrochloride |
| Patents: | 0 |
Medical Subject Heading (MeSH) Categories for 086833
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | SYRUP;ORAL | Strength | 2MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | Yes | |||||
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