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FDA NDA · NDA019152

CALAN SR

Sponsor: PFIZER

APPLICATION
NDA019152
TYPE
NDA
ORIGINAL APPROVAL
1986-12-16
LATEST ACTION
2020-05-22
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

CALAN SR · ReferenceDiscontinued
VERAPAMIL HYDROCHLORIDE 180MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
CALAN SR · ReferenceDiscontinued
VERAPAMIL HYDROCHLORIDE 120MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL
CALAN SR · ReferenceDiscontinued
VERAPAMIL HYDROCHLORIDE 240MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET, EXTENDED RELEASE · ORAL

Approval history

2020-05-22Manufacturing (CMC) · Supplement 45 — Letter ↗AP
2019-10-28Labeling · Supplement 44 · standard — Label ↗AP
2017-09-14Labeling · Supplement 41 · standard — Label ↗AP
2016-08-24Labeling · Supplement 39 · standard — Letter ↗AP
2013-10-28Labeling · Supplement 38 · standard — Label ↗AP
2013-01-10Manufacturing (CMC) · Supplement 37 · standardAP
2011-12-01Labeling · Supplement 35 · unknown — Label ↗AP
2010-03-31Labeling · Supplement 33 · unknown — Label ↗AP
2009-07-01Labeling · Supplement 32 · standard — Label ↗AP
2002-11-26Manufacturing (CMC) · Supplement 30 · standard — Letter ↗AP
2001-09-28Labeling · Supplement 26 · standardAP
2001-02-14Manufacturing (CMC) · Supplement 29 · standardAP
2001-02-12Manufacturing (CMC) · Supplement 28 · standardAP
2000-07-14Manufacturing (CMC) · Supplement 27 · standardAP
1998-12-11Manufacturing (CMC) · Supplement 25 · standardAP
1998-01-13Labeling · Supplement 23 · standardAP
1997-05-16Manufacturing (CMC) · Supplement 24 · standardAP
1995-03-17Manufacturing (CMC) · Supplement 20 · standardAP
1994-07-28Manufacturing (CMC) · Supplement 15 · standardAP
1993-11-05Manufacturing (CMC) · Supplement 22 · standardAP
1992-09-23Manufacturing (CMC) · Supplement 19 · standardAP
1992-09-03Labeling · Supplement 17AP
1992-05-04Manufacturing (CMC) · Supplement 16 · standardAP
1991-03-06Manufacturing (CMC) · Supplement 14 · standardAP
1991-03-06Manufacturing (CMC) · Supplement 6 · standardAP
1990-01-19Manufacturing (CMC) · Supplement 13 · standardAP
1989-12-15Efficacy · Supplement 9AP
1989-08-08Manufacturing (CMC) · Supplement 7 · standardAP
1989-06-14Manufacturing (CMC) · Supplement 10 · standardAP
1989-05-17Manufacturing (CMC) · Supplement 12 · standardAP
1989-03-30Manufacturing (CMC) · Supplement 11 · standardAP
1988-11-30Manufacturing (CMC) · Supplement 4 · standardAP
1988-11-30Manufacturing (CMC) · Supplement 2 · standardAP
1988-11-30Manufacturing (CMC) · Supplement 3 · standardAP
1988-09-22Labeling · Supplement 8AP
1988-07-20Labeling · Supplement 5AP
1987-09-24Manufacturing (CMC) · Supplement 1 · standardAP
1986-12-16Type 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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