← FDA DRUG APPROVALS

FDA NDA · NDA019614

VERAPAMIL HYDROCHLORIDE

Sponsor: AZURITY

APPLICATION
NDA019614
TYPE
NDA
ORIGINAL APPROVAL
1990-05-29
LATEST ACTION
2019-10-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

VERELAN · ReferencePrescription
VERAPAMIL HYDROCHLORIDE 120MG · CAPSULE, EXTENDED RELEASE · ORAL
VERELAN · ReferencePrescription
VERAPAMIL HYDROCHLORIDE 360MG · CAPSULE, EXTENDED RELEASE · ORAL
VERELAN · ReferencePrescription
VERAPAMIL HYDROCHLORIDE 240MG · CAPSULE, EXTENDED RELEASE · ORAL
VERELAN · ReferencePrescription
VERAPAMIL HYDROCHLORIDE 180MG · CAPSULE, EXTENDED RELEASE · ORAL

Approval history

2019-10-01Labeling · Supplement 56 · standard — Letter ↗AP
2016-11-18Labeling · Supplement 53 · standard — Letter ↗AP
2014-10-09Labeling · Supplement 50 · unknown — Label ↗AP
2011-11-14Labeling · Supplement 49 · unknown — Label ↗AP
2010-03-30Labeling · Supplement 45 · unknown — Letter ↗AP
2010-03-30Labeling · Supplement 34 · standard — Letter ↗AP
2000-11-29Manufacturing (CMC) · Supplement 32 · standardAP
2000-07-27Manufacturing (CMC) · Supplement 31 · standardAP
1999-12-13Manufacturing (CMC) · Supplement 30 · standardAP
1999-07-02Manufacturing (CMC) · Supplement 28 · standardAP
1999-06-05Labeling · Supplement 27 · standardAP
1998-10-15Manufacturing (CMC) · Supplement 26 · standardAP
1998-07-14Labeling · Supplement 24 · standardAP
1997-12-30Manufacturing (CMC) · Supplement 23 · standardAP
1997-07-29Labeling · Supplement 25 · standardAP
1997-04-23Manufacturing (CMC) · Supplement 22 · standardAP
1996-05-31Manufacturing (CMC) · Supplement 20 · standardAP
1996-05-31Manufacturing (CMC) · Supplement 19 · standardAP
1996-05-16Manufacturing (CMC) · Supplement 18 · standardAP
1996-05-10Manufacturing (CMC) · Supplement 13 · standardAP
1996-02-01Manufacturing (CMC) · Supplement 17 · standardAP
1995-08-02Manufacturing (CMC) · Supplement 16 · standardAP
1995-06-21Labeling · Supplement 11 · standardAP
1994-10-12Labeling · Supplement 6AP
1994-08-18Manufacturing (CMC) · Supplement 2 · standardAP
1994-04-05Manufacturing (CMC) · Supplement 1 · standardAP
1994-03-30Manufacturing (CMC) · Supplement 10 · standardAP
1993-12-06Labeling · Supplement 9 · standardAP
1993-11-08Labeling · Supplement 12 · standardAP
1992-10-02Labeling · Supplement 7AP
1992-10-02Labeling · Supplement 8AP
1992-01-09Manufacturing (CMC) · Supplement 3 · standardAP
1991-09-13Labeling · Supplement 5AP
1991-06-06Labeling · Supplement 4AP
1990-05-29Type 3 - New Dosage Form · Original · standardAP
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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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