APPLICATION
ANDA088441
TYPE
ANDA
ORIGINAL APPROVAL
1984-05-29
LATEST ACTION
2002-03-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
URECHOLINE · ReferenceDiscontinued
BETHANECHOL CHLORIDE 25MG · TABLET · ORAL
Approval history
2002-03-12Labeling · Supplement 19AP
2002-03-12Manufacturing (CMC) · Supplement 18AP
2001-10-25Manufacturing (CMC) · Supplement 16AP
2001-10-12Manufacturing (CMC) · Supplement 17AP
2000-10-25Manufacturing (CMC) · Supplement 15AP
2000-10-02Manufacturing (CMC) · Supplement 14AP
2000-08-03Manufacturing (CMC) · Supplement 13AP
2000-02-24Manufacturing (CMC) · Supplement 12AP
1996-05-22Labeling · Supplement 11AP
1994-05-11Manufacturing (CMC) · Supplement 10AP
1992-05-14Labeling · Supplement 9AP
1992-02-28Labeling · Supplement 8AP
1991-08-01Manufacturing (CMC) · Supplement 5AP
1991-03-25Labeling · Supplement 7AP
1986-06-30Manufacturing (CMC) · Supplement 2AP
1986-05-15Manufacturing (CMC) · Supplement 3AP
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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