APPLICATION
ANDA089096
TYPE
ANDA
ORIGINAL APPROVAL
1985-12-19
LATEST ACTION
2005-03-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
URECHOLINEDiscontinued
BETHANECHOL CHLORIDE 50MG · TABLET · ORAL
Approval history
2005-03-03Labeling · Supplement 20AP
2001-10-25Manufacturing (CMC) · Supplement 12AP
2001-10-12Manufacturing (CMC) · Supplement 13AP
2001-07-20Manufacturing (CMC) · Supplement 14AP
2000-10-25Manufacturing (CMC) · Supplement 11AP
2000-10-02Manufacturing (CMC) · Supplement 10AP
1996-05-22Labeling · Supplement 9AP
1994-05-11Manufacturing (CMC) · Supplement 8AP
1992-05-14Labeling · Supplement 7AP
1992-03-31Manufacturing (CMC) · Supplement 3AP
1992-02-28Labeling · Supplement 6AP
1991-03-25Labeling · Supplement 5AP
1986-07-30Manufacturing (CMC) · Supplement 1AP
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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