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Details for New Drug Application (NDA): 091295

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NDA 091295 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: 091295

Pharm Assoc
cyproheptadine hydrochloride
Therapeutic Class:Respiratory Tract Agents

Suppliers and Packaging for NDA: 091295

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cyproheptadine hydrochloride
SYRUP;ORAL 091295 ANDA Pharmaceutical Associates, Inc. 0121-0788 0121-0788-16 473 mL in 1 BOTTLE (0121-0788-16)
cyproheptadine hydrochloride
SYRUP;ORAL 091295 ANDA Pharmaceutical Associates, Inc. 0121-4788 0121-4788-05 4 TRAY in 1 CASE (0121-4788-05) > 10 CUP, UNIT-DOSE in 1 TRAY > 5 mL in 1 CUP, UNIT-DOSE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SYRUP;ORALStrength2MG/5ML
Approval Date:Mar 28, 2013TE:AARLD:No

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