APPLICATION
NDA018817
TYPE
NDA
ORIGINAL APPROVAL
1984-09-10
LATEST ACTION
2021-11-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
CALANDiscontinued
VERAPAMIL HYDROCHLORIDE 40MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CALAN · ReferenceDiscontinued
VERAPAMIL HYDROCHLORIDE 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CALANDiscontinued
VERAPAMIL HYDROCHLORIDE 160MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
CALAN · ReferenceDiscontinued
VERAPAMIL HYDROCHLORIDE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL
Approval history
2013-02-13Manufacturing (CMC) · Supplement 29 · standardAP
1998-01-13Labeling · Supplement 19 · standardAP
1996-05-14Manufacturing (CMC) · Supplement 18 · standardAP
1996-02-07Manufacturing (CMC) · Supplement 17 · standardAP
1994-11-04Labeling · Supplement 16 · standardAP
1991-09-27Labeling · Supplement 15AP
1991-08-12Labeling · Supplement 14AP
1990-02-14Labeling · Supplement 13AP
1988-04-13Labeling · Supplement 12AP
1988-02-23Labeling · Supplement 11AP
1988-02-23Efficacy · Supplement 7AP
1987-04-29Manufacturing (CMC) · Supplement 8 · standardAP
1987-04-29Labeling · Supplement 10AP
1987-04-29Labeling · Supplement 9AP
1986-12-16Efficacy · Supplement 3AP
1986-10-20Manufacturing (CMC) · Supplement 4 · standardAP
1986-06-27Labeling · Supplement 6AP
1986-05-06Manufacturing (CMC) · Supplement 5 · standardAP
1985-06-04Manufacturing (CMC) · Supplement 1 · standardAP
1984-09-10Type 5 - New Formulation or New Manufacturer · 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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