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Generated: October 19, 2017

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 Morton Grove, Pliva, Superpharm, Sandoz, Tg United Labs, Naska, Bio-pharm Inc, Par Pharm, Duramed Pharms Barr, Actavis Mid Atlantic, Impax Labs Inc, Kv Pharm, Zydus Pharms Usa Inc, Pioneer Pharms, Santos Biotech, Watson Labs, Appco Pharma Llc, Ailex Pharms Llc, Ivax Sub Teva Pharms, Halsey, Md Pharm, Lyne, Mylan, Apex Pharms Inc, Vitarine, Ascot, Ingenus Pharms Nj, Silarx Pharms Inc, Pharm Assoc, and Am Therap, and is included in thirty-three NDAs. It is available from twenty-five 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-five suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.

Summary for NDA: 040644

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
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 0463-6080-01 100 TABLET in 1 BOTTLE (0463-6080-01)
CYPROHEPTADINE HYDROCHLORIDE
cyproheptadine hydrochloride
TABLET;ORAL 040644 ANDA AvKARE, Inc. 42291-225 42291-225-01 100 TABLET in 1 BOTTLE (42291-225-01)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

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