← FDA DRUG APPROVALS

FDA ANDA · ANDA084441

BETHANECHOL CHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA084441
TYPE
ANDA
ORIGINAL APPROVAL
1975-01-14
LATEST ACTION
1996-04-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BETHANECHOL CHLORIDEDiscontinued
BETHANECHOL CHLORIDE 25MG · TABLET · ORAL

Approval history

1996-04-18Labeling · Supplement 46AP
1991-05-31Manufacturing (CMC) · Supplement 43AP
1991-03-22Labeling · Supplement 45AP
1991-01-28Manufacturing (CMC) · Supplement 44AP
1990-06-29Manufacturing (CMC) · Supplement 42AP
1988-03-16Manufacturing (CMC) · Supplement 40AP
1988-03-16Manufacturing (CMC) · Supplement 39AP
1988-03-16Manufacturing (CMC) · Supplement 41AP
1987-08-11Manufacturing (CMC) · Supplement 37AP
1985-07-19Manufacturing (CMC) · Supplement 34AP
1984-03-08Manufacturing (CMC) · Supplement 33AP
1983-08-02Manufacturing (CMC) · Supplement 30AP
1982-04-12Manufacturing (CMC) · Supplement 25AP
1975-01-14OriginalAP
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 →