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Last Updated: October 4, 2024

Details for New Drug Application (NDA): 205087


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NDA 205087 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, 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 205087
Tradename:CYPROHEPTADINE HYDROCHLORIDE
Applicant:Novast Labs
Ingredient:cyproheptadine hydrochloride
Patents:0
Suppliers and Packaging for NDA: 205087
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYPROHEPTADINE HYDROCHLORIDE cyproheptadine hydrochloride TABLET;ORAL 205087 ANDA Ingenus Pharmaceuticals LLC 50742-190 50742-190-01 100 TABLET in 1 BOTTLE, PLASTIC (50742-190-01)
CYPROHEPTADINE HYDROCHLORIDE cyproheptadine hydrochloride TABLET;ORAL 205087 ANDA Ingenus Pharmaceuticals LLC 50742-190 50742-190-10 1000 TABLET in 1 BOTTLE, PLASTIC (50742-190-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Sep 23, 2015TE:AARLD:No

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