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EXTENDED PHENYTOIN SODIUM

ANDA

PHENYTOIN SODIUM | A040731 | SUN PHARMACEUTICAL INDUSTRIES LTD

2 strengths0 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.

Products (2)

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#001 — 200MG EXTENDED

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Jun 30, 2008

No patent or exclusivity listings for this strength.

#002 — 300MG EXTENDED

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Jun 30, 2008