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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 213784


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NDA 213784 describes FLUPHENAZINE HYDROCHLORIDE, which is a drug marketed by Ani Pharms, Pharm Assoc, Fresenius Kabi Usa, Ajanta Pharma Ltd, Alembic, Amneal, Apotex, Aurobindo Pharma Ltd, Chartwell Rx, Dr Reddys, Glenmark Pharms Ltd, Lannett Co Inc, MSN, Novitium Pharma, Prasco, Rising, Sandoz, Taro, Torrent, Twi Pharms, Upsher Smith Labs, Watson Labs, and Zydus Lifesciences, and is included in twenty-nine NDAs. It is available from thirty suppliers. Additional details are available on the FLUPHENAZINE HYDROCHLORIDE profile page.

The generic ingredient in FLUPHENAZINE HYDROCHLORIDE is fluphenazine hydrochloride. There are nineteen drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the fluphenazine hydrochloride profile page.
Summary for 213784
Pharmacology for NDA: 213784
Suppliers and Packaging for NDA: 213784
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 213784 ANDA Upsher-Smith Laboratories,LLC 0832-6003 0832-6003-11 100 TABLET, FILM COATED in 1 BOTTLE (0832-6003-11)
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 213784 ANDA Upsher-Smith Laboratories,LLC 0832-6004 0832-6004-11 100 TABLET, FILM COATED in 1 BOTTLE (0832-6004-11)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Oct 24, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Oct 24, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Oct 24, 2022TE:ABRLD:No

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