APPLICATION
NDA008732
TYPE
NDA
ORIGINAL APPROVAL
1953-04-02
LATEST ACTION
1989-02-17
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
PRO-BANTHINE · ReferenceDiscontinued
PROPANTHELINE BROMIDE 7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
PRO-BANTHINE · ReferenceDiscontinued
PROPANTHELINE BROMIDE 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1989-02-17Labeling · Supplement 34AP
1988-02-11Labeling · Supplement 32AP
1988-02-11Labeling · Supplement 29AP
1988-02-11Labeling · Supplement 33AP
1983-06-09Manufacturing (CMC) · Supplement 31 · standardAP
1981-04-06Manufacturing (CMC) · Supplement 28 · standardAP
1981-03-18Labeling · Supplement 26AP
1981-03-18Labeling · Supplement 24AP
1981-03-18Labeling · Supplement 25AP
1981-03-18Labeling · Supplement 21AP
1979-11-30Manufacturing (CMC) · Supplement 23 · standardAP
1953-04-02Type 1 - New Molecular Entity · Original · standardAP
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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