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FOSPHENYTOIN SODIUM

ANDA

FOSPHENYTOIN SODIUM | A078277 | AMERICAN REGENT INC

1 strength0 unique patents0 unique exclusivities

API Supply Chain5 active DMFs5 inactive

5 active API suppliers hold Drug Master Files for this ingredient.

SHANGHAI ZIYUAN PHARMACEUTICAL CO LTDFOSPHENYTOIN SODIUM USP

DMF 173332004

SUN PHARMACEUTICAL INDUSTRIES LTDFOSPHENYTOIN SODIUM USP

DMF 194552006

GUANG'AN KINGDAY PHARMA AND CHEM CO LTDFOSPHENYTOIN SODIUM USP

DMF 328162018

GLAND PHARMA LTDFOSPHENYTOIN SODIUM

DMF 337562019

CHEMWERTH INCFOSPHENYTOIN SODIUM USP

DMF 375652023

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAInactiveFOSPHENYTOIN SODIUM API

DMF 168992003

DIVIS LABORATORIES LTDInactiveFOSPHENYTOIN SODIUM USP

DMF 188062005

CILAG AGInactiveFOSPHENYTOIN SODIUM DRUG SUBSTANCE (ACTIVE PHARMACEUTICAL INGREDIENT)

DMF 189542005

DR REDDYS LABORATORIES LTDInactiveFOSPHENYTOIN SODIUM

DMF 205112007

TRIFARMA SPAInactiveFOSPHENYTOIN SODIUM

DMF 209702007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Aug 7, 2007	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 50MG PHENYTOIN NA/ML

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Aug 6, 2007

No patent or exclusivity listings for this strength.