← FDA DRUG APPROVALS

FDA NDA · NDA020943

VERAPAMIL HYDROCHLORIDE

Sponsor: AZURITY

APPLICATION
NDA020943
TYPE
NDA
ORIGINAL APPROVAL
1998-11-25
LATEST ACTION
2019-10-03
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

VERELAN PM · ReferencePrescription
VERAPAMIL HYDROCHLORIDE 100MG · CAPSULE, EXTENDED RELEASE · ORAL
VERELAN PM · ReferencePrescription
VERAPAMIL HYDROCHLORIDE 200MG · CAPSULE, EXTENDED RELEASE · ORAL
VERELAN PM · ReferencePrescription
VERAPAMIL HYDROCHLORIDE 300MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2019-10-03Labeling · Supplement 35 · standard — Label ↗AP
2016-11-18Labeling · Supplement 32 · standard — Letter ↗AP
2014-10-14Labeling · Supplement 29 · standard — Letter ↗AP
2011-11-14Labeling · Supplement 28 · unknown — Label ↗AP
2010-04-01Labeling · Supplement 7 · standard — Label ↗AP
2010-04-01Labeling · Supplement 26 · unknown — Letter ↗AP
2009-12-16Labeling · Supplement 21 · standard — Label ↗AP
2007-05-01Labeling · Supplement 20 · standard — Letter ↗AP
2004-05-05Labeling · Supplement 13 · standard — Label ↗AP
2002-12-26Manufacturing (CMC) · Supplement 9 · standardAP
2000-11-29Manufacturing (CMC) · Supplement 5 · standardAP
2000-07-27Manufacturing (CMC) · Supplement 4 · standardAP
1999-12-13Manufacturing (CMC) · Supplement 3 · standardAP
1999-07-02Manufacturing (CMC) · Supplement 1 · standardAP
1999-06-04Labeling · Supplement 2 · standardAP
1998-11-25Type 3 - New Dosage Form · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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