APPLICATION
ANDA085882
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-22
LATEST ACTION
2005-01-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DUVOIDPrescription
BETHANECHOL CHLORIDE 50MG · TABLET · ORAL
Approval history
2005-01-28Labeling · Supplement 25AP
1990-01-11Labeling · Supplement 14AP
1988-11-17Manufacturing (CMC) · Supplement 18AP
1985-03-12Manufacturing (CMC) · Supplement 11AP
1983-05-09Manufacturing (CMC) · Supplement 10AP
1978-03-22OriginalAP
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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