Viewing data from:

DILANTIN

ANDA

PHENYTOIN | A084427 | PHARMACIA AND UPJOHN CO LLC

1 strength0 unique patents0 unique exclusivities

API Supply Chain3 active DMFs2 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAPHENYTOIN MICRO

DMF 45311982

KUNSHAN ORIENTAL PHARMACEUTICAL CO LTDPHENYTOIN

DMF 204342007

RECORDATI INDUSTRIA CHIMICA E FARMACEUTICA SPAPHENYTOIN

DMF 232262009

PARKE DAVIS DIV WARNER LAMBERT COInactivePHENYTOIN USP & PHENYTOIN SODIUM USP

DMF 72291987

CADILA LABORATORIES PVT LTDInactivePHENYTOIN USP & PHENYTOIN SODIUM USP

DMF 73481988

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 50MG

RLDAB

0 patents0 exclusivities▴

TABLET, CHEWABLE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.