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Details for New Drug Application (NDA): 040537

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NDA 040537 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: 040537

cyproheptadine hydrochloride
Therapeutic Class:Respiratory Tract Agents

Suppliers and Packaging for NDA: 040537

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
cyproheptadine hydrochloride
TABLET;ORAL 040537 ANDA REMEDYREPACK INC. 49349-530 49349-530-02 30 TABLET in 1 BLISTER PACK (49349-530-02)
cyproheptadine hydrochloride
TABLET;ORAL 040537 ANDA State of Florida DOH Central Pharmacy 53808-0950 53808-0950-1 30 TABLET in 1 BLISTER PACK (53808-0950-1)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength4MG
Approval Date:Sep 30, 2003TE:AARLD:No

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