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OXYBUTYNIN CHLORIDE

ANDA

OXYBUTYNIN CHLORIDE | A076644 | PHARMOBEDIENT CONSULTING LLC

2 strengths0 unique patents0 unique exclusivities

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Foley & Lardner LLP FDA-2019-P-4507 · 3 docket documents Foley & Lardner LLP filed a citizen petition under Section 505(j) requesting that the FDA designate the Accord Healthcare Inc. ANDA for Oxybutynin Chloride Extended Release Tablets 15 mg as an additional reference standard because the original reference listed drug, DITROPAN XL, is discontinued and	Other	2019-09-26	Withdrawn	Foley & Lardner LLP

Source: Regulations.gov. FDA citizen petitions matched by application number.

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 (2)

Sort:

#001 — 10MG

0 patents0 exclusivities▴

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

No patent or exclusivity listings for this strength.

#002 — 15MG

0 patents0 exclusivities▾

TABLET, EXTENDED RELEASE;ORAL | Approved: May 10, 2007