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Generated: March 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 040644

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NDA 040644 describes CYPROHEPTADINE HYDROCHLORIDE, which is a drug marketed by Actavis Mid Atlantic, Bio-pharm Inc, Halsey, Lyne, Morton Grove, Naska, Pharm Assoc, Silarx Pharms Inc, Ailex Pharms Llc, Am Therap, Apex Pharms Inc, Appco Pharma Llc, Ascot, Chartwell Rx, Duramed Pharms Barr, Fosun Pharma, Ingenus Pharms Nj, Ivax Sub Teva Pharms, Kv Pharm, Md Pharm, Mountain, Mylan, Par Pharm, Pioneer Pharms, Pliva, Santos Biotech, Superpharm, Vitarine, Watson Labs, and Zydus Pharms Usa Inc, and is included in thirty-three 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 040644
Applicant:Santos Biotech
Ingredient:cyproheptadine hydrochloride
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 040644
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYPROHEPTADINE HYDROCHLORIDE cyproheptadine hydrochloride TABLET;ORAL 040644 ANDA C.O. Truxton, Inc. 0463-6080 E 0463-6080-01
CYPROHEPTADINE HYDROCHLORIDE cyproheptadine hydrochloride TABLET;ORAL 040644 ANDA AvKARE, Inc. 42291-225 N 42291-225-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:May 30, 2006TE:AARLD:No

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