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FDA ANDA · ANDA074587

VERAPAMIL HYDROCHLORIDE

Sponsor: RISING

APPLICATION
ANDA074587
TYPE
ANDA
ORIGINAL APPROVAL
1996-03-23
LATEST ACTION
2020-05-18
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

VERAPAMIL HYDROCHLORIDEDiscontinued
VERAPAMIL HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL
VERAPAMIL HYDROCHLORIDEDiscontinued
VERAPAMIL HYDROCHLORIDE 180MG · TABLET, EXTENDED RELEASE · ORAL
VERAPAMIL HYDROCHLORIDEDiscontinued
VERAPAMIL HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2020-05-18Labeling · Supplement 42 · standardAP
2019-09-24Labeling · Supplement 39 · standardAP
2019-09-24Labeling · Supplement 40 · standardAP
2015-10-15Labeling · Supplement 37 · standardAP
2015-10-15Labeling · Supplement 36 · standardAP
2010-07-31Labeling · Supplement 33AP
2010-03-15Labeling · Supplement 32AP
2008-03-21Labeling · Supplement 25AP
2002-07-25Manufacturing (CMC) · Supplement 19AP
2002-02-08Labeling · Supplement 18AP
2001-03-30Labeling · Supplement 17AP
2000-10-05Manufacturing (CMC) · Supplement 16AP
2000-10-05Manufacturing (CMC) · Supplement 15AP
2000-10-05Manufacturing (CMC) · Supplement 13AP
2000-08-07Labeling · Supplement 14AP
1998-05-18Manufacturing (CMC) · Supplement 12AP
1997-09-19Manufacturing (CMC) · Supplement 10AP
1997-09-19Manufacturing (CMC) · Supplement 8AP
1997-09-19Labeling · Supplement 11AP
1997-09-19Manufacturing (CMC) · Supplement 9AP
1997-09-19Manufacturing (CMC) · Supplement 7AP
1997-02-21Labeling · Supplement 6AP
1997-02-21Manufacturing (CMC) · Supplement 4AP
1997-02-21Manufacturing (CMC) · Supplement 5AP
1997-02-21Manufacturing (CMC) · Supplement 3AP
1997-02-21Manufacturing (CMC) · Supplement 1AP
1996-11-15Manufacturing (CMC) · Supplement 2AP
1996-03-23OriginalAP
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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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