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OXYBUTYNIN

ANDA

OXYBUTYNIN | A090526 | BARR LABORATORIES INC SUB TEVA PHARMACEUTICALS USA

1 strength0 unique patents0 unique exclusivities

API Supply Chain4 active DMFs2 inactive

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

SIEGFRIED EVIONNAZ SAOXYBUTYNIN BASE

DMF 119471996

CORDEN PHARMA CHENOVEOXYBUTYNIN HYDROCHLORIDE

DMF 123091997

PCASOXYBUTYNIN BASE

DMF 130841998

TAPI NL BVOXYBUTYNIN BASE

DMF 260772012

SELOC AGInactiveOXYBUTYNIN BASE

DMF 114781995

JUZEN CHEMICAL CORPInactiveOXYBUTYNIN

DMF 140711999

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Mar 6, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 3.9MG/24HR

0 patents0 exclusivities▴

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Mar 4, 2014

No patent or exclusivity listings for this strength.