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Last Updated: October 26, 2021

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Details for New Drug Application (NDA): 207555


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NDA 207555 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, Appco, 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, Rising, Strides Pharma, Superpharm, Vitarine, Watson Labs, and Zydus Pharms, and is included in thirty-eight NDAs. It is available from twenty-four 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-four suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.
Summary for 207555
Tradename:CYPROHEPTADINE HYDROCHLORIDE
Applicant:Elysium
Ingredient:cyproheptadine hydrochloride
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 207555
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYPROHEPTADINE HYDROCHLORIDE cyproheptadine hydrochloride TABLET;ORAL 207555 ANDA Marlex Pharmaceuticals Inc 10135-638 10135-638-01 100 TABLET in 1 BOTTLE (10135-638-01)
CYPROHEPTADINE HYDROCHLORIDE cyproheptadine hydrochloride TABLET;ORAL 207555 ANDA Marlex Pharmaceuticals Inc 10135-638 10135-638-10 1000 TABLET in 1 BOTTLE (10135-638-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Jan 31, 2017TE:AARLD:No

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