APPLICATION
NDA018593
TYPE
NDA
ORIGINAL APPROVAL
1982-03-08
LATEST ACTION
1999-09-14
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
ISOPTIN · ReferenceDiscontinued
VERAPAMIL HYDROCHLORIDE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ISOPTIN · ReferenceDiscontinued
VERAPAMIL HYDROCHLORIDE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
ISOPTIN · ReferenceDiscontinued
VERAPAMIL HYDROCHLORIDE 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
1999-09-14Manufacturing (CMC) · Supplement 15 · priorityAP
1988-12-15Manufacturing (CMC) · Supplement 10 · priorityAP
1988-07-20Labeling · Supplement 14AP
1988-06-22Manufacturing (CMC) · Supplement 13 · priorityAP
1987-11-23Manufacturing (CMC) · Supplement 12 · priorityAP
1987-07-28Manufacturing (CMC) · Supplement 11 · priorityAP
1986-12-16Efficacy · Supplement 6AP
1986-12-16Efficacy · Supplement 4AP
1984-09-10Manufacturing (CMC) · Supplement 8 · priorityAP
1984-09-10Manufacturing (CMC) · Supplement 7 · priorityAP
1982-07-27Manufacturing (CMC) · Supplement 1 · priorityAP
1982-03-08Type 3 - New Dosage Form · Original · priorityAP
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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