APPLICATION
ANDA086263
TYPE
ANDA
ORIGINAL APPROVAL
1978-03-22
LATEST ACTION
2004-06-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
DUVOIDPrescription
BETHANECHOL CHLORIDE 25MG · TABLET · ORAL
Approval history
2004-06-28Labeling · Supplement 22AP
1996-07-11Labeling · Supplement 15AP
1989-12-28Labeling · Supplement 14AP
1988-11-15Labeling · Supplement 13AP
1983-09-29Manufacturing (CMC) · Supplement 11AP
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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