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Details for New Drug Application (NDA): 074725

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NDA 074725 describes FLUPHENAZINE HYDROCHLORIDE, which is a drug marketed by Mylan, Ani Pharms Inc, Pharm Assoc, Watson Labs, Lannett, Fresenius Kabi Usa, Teva Pharms, and Sandoz, and is included in fifteen NDAs. It is available from twelve suppliers. Additional details are available on the FLUPHENAZINE HYDROCHLORIDE profile page.

The generic ingredient in FLUPHENAZINE HYDROCHLORIDE is fluphenazine hydrochloride. There are eighteen drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the fluphenazine hydrochloride profile page.

Summary for NDA: 074725

Pharm Assoc
fluphenazine hydrochloride
Therapeutic Class:Antipsychotics

Pharmacology for NDA: 074725


Suppliers and Packaging for NDA: 074725

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
fluphenazine hydrochloride
CONCENTRATE;ORAL 074725 ANDA Pharmaceutical Associates, Inc. 0121-0653 0121-0653-04 120 mL in 1 BOTTLE, DROPPER (0121-0653-04)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CONCENTRATE;ORALStrength5MG/ML
Approval Date:Sep 16, 1996TE:RLD:Yes

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