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OXYBUTYNIN CHLORIDE

ANDA

OXYBUTYNIN CHLORIDE | A076745 | IMPAX PHARMACEUTICALS

3 strengths0 unique patents0 unique exclusivities

API Supply Chain6 active DMFs4 inactive

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

PCASOXYBUTYNIN CHLORIDE USP

DMF 64121986

APITORIA PHARMA PRIVATE LTDOXYBUTYNIN CHLORIDE

DMF 194472006

HARMAN FINOCHEM LTDOXYBUTYNIN CHLORIDE

DMF 228522009

RESONANCE LABORATORIES PVT LTDOXYBUTYNIN CHLORIDE (OBTN)

DMF 237572010

TAPI NL BVOXYBUTYNIN CHLORIDE USP

DMF 265372012

THINQ PHARMA-CRO LTDOXYBUTYNIN CHLORIDE USP

DMF 343362020

ZEELAND CHEMICALS INCInactiveOXYBUTYNIN CHLORIDE

DMF 62721986

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveOXYBUTYNIN CHLORIDE

DMF 63691986

SANOFI AVENTIS SPAInactiveOXYBUTYNIN CHLORIDE

DMF 128401998

WOCKHARDT BIO AGInactiveOXYBUTYNIN CHLORIDE USP

DMF 160612002

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 14, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 15MG

0 patents0 exclusivities▴

TABLET, EXTENDED RELEASE;ORAL | Approved: Nov 9, 2006

No patent or exclusivity listings for this strength.

#002 — 5MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 9, 2007

#003 — 10MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 9, 2007