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FDA ANDA · ANDA087444

BETHANECHOL CHLORIDE

Sponsor: WATSON LABS

APPLICATION
ANDA087444
TYPE
ANDA
ORIGINAL APPROVAL
1981-07-16
LATEST ACTION
1997-11-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

BETHANECHOL CHLORIDEDiscontinued
BETHANECHOL CHLORIDE 50MG · TABLET · ORAL

Approval history

1997-11-07Manufacturing (CMC) · Supplement 15AP
1996-04-18Labeling · Supplement 14AP
1991-05-31Manufacturing (CMC) · Supplement 11AP
1991-03-22Labeling · Supplement 13AP
1991-01-28Manufacturing (CMC) · Supplement 12AP
1990-06-29Manufacturing (CMC) · Supplement 10AP
1988-01-29Manufacturing (CMC) · Supplement 9AP
1981-07-16OriginalAP
VIEW ON DRUGS@FDA ↗

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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.

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