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Details for New Drug Application (NDA): 040668

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NDA 040668 describes CYPROHEPTADINE HYDROCHLORIDE, which is a drug marketed by Morton Grove, Pliva, Superpharm, Sandoz, Tg United Labs, Naska, Par Pharm, Duramed Pharms Barr, Actavis Mid Atlantic, Corepharma, Kv Pharm, Pioneer Pharms, Stason Pharms, Watson Labs, Ivax Sub Teva Pharms, Halsey, Md Pharm, Lyne, Mylan, Vitarine, Ascot, Ingenus Pharms Nj, Pharm Assoc, and Am Therap, and is included in twenty-seven NDAs. It is available from seventeen 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. Seventeen suppliers are listed for this compound. Additional details are available on the cyproheptadine hydrochloride profile page.

Summary for NDA: 040668

Tradename:
CYPROHEPTADINE HYDROCHLORIDE
Applicant:
Lyne
Ingredient:
cyproheptadine hydrochloride
Patents:0
Therapeutic Class:Respiratory Tract Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 040668

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYPROHEPTADINE HYDROCHLORIDE
cyproheptadine hydrochloride
SYRUP;ORAL 040668 ANDA Actavis Mid Atlantic LLC 0472-1400 0472-1400-16 473 mL in 1 BOTTLE (0472-1400-16)
CYPROHEPTADINE HYDROCHLORIDE
cyproheptadine hydrochloride
SYRUP;ORAL 040668 ANDA Physicians Total Care, Inc. 54868-4338 54868-4338-0 473 mL in 1 BOTTLE (54868-4338-0)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength2MG/5ML
Approval Date:Jun 28, 2006TE:AARLD:Yes


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