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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 214534


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NDA 214534 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-one 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-one suppliers are listed for this compound. Additional details are available on the fluphenazine hydrochloride profile page.
Summary for 214534
Tradename:FLUPHENAZINE HYDROCHLORIDE
Applicant:Dr Reddys
Ingredient:fluphenazine hydrochloride
Patents:0
Pharmacology for NDA: 214534
Suppliers and Packaging for NDA: 214534
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 214534 ANDA Dr. Reddy?s Laboratories Inc. 43598-034 43598-034-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43598-034-01)
FLUPHENAZINE HYDROCHLORIDE fluphenazine hydrochloride TABLET;ORAL 214534 ANDA Dr. Reddy?s Laboratories Inc. 43598-035 43598-035-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43598-035-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jan 7, 2021TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength2.5MG
Approval Date:Jan 7, 2021TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength5MG
Approval Date:Jan 7, 2021TE:ABRLD:No

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