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EXTENDED PHENYTOIN SODIUM

ANDA

PHENYTOIN SODIUM | A204309 | AUROBINDO PHARMA LTD

1 strength0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs

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

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAPHENYTOIN SODIUM

DMF 45381982

ERREDUE SPA INNOVATIVE CHEMICAL AND LIFEPHENYTOIN SODIUM

DMF 163012002

HARMAN FINOCHEM LTDPHENYTOIN SODIUM USP

DMF 178622004

KUNSHAN ORIENTAL PHARMACEUTICAL CO LTDPHENYTOIN SODIUM

DMF 204332007

ORCHID PHARMA LTDPHENYTOIN SODIUM

DMF 204532007

UNICHEM LABORATORIES LTDPHENYTOIN SODIUM USP

DMF 326762018

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jun 12, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG EXTENDED

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 10, 2015

No patent or exclusivity listings for this strength.