APPLICATION
NDA010679
TYPE
NDA
ORIGINAL APPROVAL
1956-11-14
LATEST ACTION
2004-05-25
ROUTE
ORAL
DOSAGE FORM
TABLET, SOLUTION
MARKETING STATUS
Discontinued
Products
CANTIL · ReferenceDiscontinued
MEPENZOLATE BROMIDE 25MG · TABLET · ORAL
CANTILDiscontinued
MEPENZOLATE BROMIDE 25MG/5ML · SOLUTION · ORAL
Approval history
1999-01-29Manufacturing (CMC) · Supplement 27 · standardAP
1991-05-08Labeling · Supplement 23AP
1989-01-11Manufacturing (CMC) · Supplement 26 · standardAP
1985-07-15Manufacturing (CMC) · Supplement 25 · standardAP
1982-11-09Manufacturing (CMC) · Supplement 19 · standardAP
1982-11-09Manufacturing (CMC) · Supplement 24 · standardAP
1980-11-04Labeling · Supplement 21AP
1980-06-20Labeling · Supplement 17AP
1956-11-14Type 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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