← FDA DRUG APPROVALS

FDA NDA · NDA020838

ATACAND

candesartan cilexetil

Sponsor: ANI PHARMS

APPLICATION
NDA020838
TYPE
NDA
ORIGINAL APPROVAL
1998-06-04
LATEST ACTION
2020-06-24
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

ATACAND · ReferencePrescription
CANDESARTAN CILEXETIL 16MG · TABLET · ORAL
ATACAND · ReferencePrescription
CANDESARTAN CILEXETIL 4MG · TABLET · ORAL
ATACAND · ReferencePrescription
CANDESARTAN CILEXETIL 32MG · TABLET · ORAL
ATACAND · ReferencePrescription
CANDESARTAN CILEXETIL 8MG · TABLET · ORAL

Approval history

2020-06-24Labeling · Supplement 41 · standard — Label ↗AP
2016-02-09Labeling · Supplement 39 · standard — Letter ↗AP
2015-02-06Labeling · Supplement 36 · standard — Label ↗AP
2013-04-26Labeling · Supplement 38 · standard — Letter ↗AP
2013-02-21Manufacturing (CMC) · Supplement 37 · standardAP
2012-04-27Labeling · Supplement 35 · unknown — Letter ↗AP
2012-04-13Labeling · Supplement 32 · unknown — Label ↗AP
2011-06-24Labeling · Supplement 33 · unknown — Label ↗AP
2009-10-22Efficacy · Supplement 31 · priority — Pediatric Written Request ↗AP
2006-08-17Labeling · Supplement 26 · standard — Letter ↗AP
2005-05-18Efficacy · Supplement 22 · priority — Label ↗AP
2005-02-22Efficacy · Supplement 24 · priority — Label ↗AP
2004-12-16Labeling · Supplement 23 · standard — Letter ↗AP
2003-04-23Labeling · Supplement 19 · standard — Letter ↗AP
2003-01-22Labeling · Supplement 17 · standard — Letter ↗AP
2002-09-13Efficacy · Supplement 15 · standard — Label ↗AP
2001-11-28Labeling · Supplement 16 · standardAP
2001-10-04Manufacturing (CMC) · Supplement 14 · standardAP
2001-06-07Manufacturing (CMC) · Supplement 10 · standardAP
2001-05-24Manufacturing (CMC) · Supplement 12 · standardAP
2001-04-02Manufacturing (CMC) · Supplement 11 · standardAP
2001-03-29Manufacturing (CMC) · Supplement 13 · standardAP
2000-12-27Manufacturing (CMC) · Supplement 9 · standardAP
2000-06-14Labeling · Supplement 8 · standard — Review ↗AP
1999-12-08Manufacturing (CMC) · Supplement 6 · standardAP
1999-08-11Manufacturing (CMC) · Supplement 5 · standardAP
1999-07-28Manufacturing (CMC) · Supplement 4 · standardAP
1998-12-07Manufacturing (CMC) · Supplement 1 · standardAP
1998-11-16Manufacturing (CMC) · Supplement 2 · standardAP
1998-06-04Type 1 - New Molecular Entity · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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