APPLICATION
ANDA080927
TYPE
ANDA
ORIGINAL APPROVAL
1974-09-09
LATEST ACTION
2000-02-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PROPANTHELINE BROMIDEDiscontinued
PROPANTHELINE BROMIDE 15MG · TABLET · ORAL
PROPANTHELINE BROMIDEDiscontinued
PROPANTHELINE BROMIDE 7.5MG · TABLET · ORAL
Approval history
2000-02-07Manufacturing (CMC) · Supplement 39AP
1999-03-12Manufacturing (CMC) · Supplement 38AP
1996-08-28Manufacturing (CMC) · Supplement 37AP
1992-02-27Manufacturing (CMC) · Supplement 35AP
1992-02-27Manufacturing (CMC) · Supplement 36AP
1991-10-04Manufacturing (CMC) · Supplement 30AP
1991-10-04Manufacturing (CMC) · Supplement 29AP
1991-10-04Manufacturing (CMC) · Supplement 31AP
1991-06-20Labeling · Supplement 34AP
1991-03-18Labeling · Supplement 33AP
1989-11-13Labeling · Supplement 28AP
1989-09-11Manufacturing (CMC) · Supplement 27AP
1986-02-25Manufacturing (CMC) · Supplement 25AP
1974-09-09OriginalAP
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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