← FDA DRUG APPROVALS

FDA ANDA · ANDA075079

OXYBUTYNIN CHLORIDE

Sponsor: STRIDES PHARMA INTL

APPLICATION
ANDA075079
TYPE
ANDA
ORIGINAL APPROVAL
1997-10-31
LATEST ACTION
2021-09-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

OXYBUTYNIN CHLORIDEPrescription
OXYBUTYNIN CHLORIDE 5MG · TABLET · ORAL
OXYBUTYNIN CHLORIDEPrescription
OXYBUTYNIN CHLORIDE 2.5MG · TABLET · ORAL

Approval history

2021-09-15Manufacturing (CMC) · Supplement 21AP
2012-06-13Labeling · Supplement 14 · standardAP
2012-04-26Labeling · Supplement 10AP
2011-11-04Labeling · Supplement 9AP
2010-03-09Labeling · Supplement 7AP
2009-01-06Labeling · Supplement 6AP
2007-02-01Labeling · Supplement 5AP
2006-02-23Labeling · Supplement 4AP
1997-10-31OriginalAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →