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FDA NDA · NDA018485

ISOPTIN

Sponsor: MT ADAMS

APPLICATION
NDA018485
TYPE
NDA
ORIGINAL APPROVAL
1981-08-12
LATEST ACTION
1998-12-11
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued

Products

ISOPTIN · ReferenceDiscontinued
VERAPAMIL HYDROCHLORIDE 2.5MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION

Approval history

1998-12-11Manufacturing (CMC) · Supplement 10 · priorityAP
1994-03-07Labeling · Supplement 9 · standard — Label ↗AP
1992-09-16Manufacturing (CMC) · Supplement 8 · priorityAP
1987-06-16Manufacturing (CMC) · Supplement 4 · priorityAP
1986-10-08Labeling · Supplement 7AP
1985-12-18Manufacturing (CMC) · Supplement 6 · priorityAP
1984-08-21Manufacturing (CMC) · Supplement 5 · priorityAP
1984-04-12Manufacturing (CMC) · Supplement 2 · priorityAP
1984-04-12Manufacturing (CMC) · Supplement 3 · priorityAP
1981-08-12Type 1 - New Molecular Entity · Original · priorityAP
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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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