← FDA DRUG APPROVALS

FDA NDA · NDA019787

NORVASC

amlodipine besylate

Sponsor: VIATRIS

APPLICATION
NDA019787
TYPE
NDA
ORIGINAL APPROVAL
1992-07-31
LATEST ACTION
2017-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

NORVASC · ReferencePrescription
AMLODIPINE BESYLATE EQ 5MG BASE · TABLET · ORAL
NORVASC · ReferencePrescription
AMLODIPINE BESYLATE EQ 10MG BASE · TABLET · ORAL
NORVASC · ReferencePrescription
AMLODIPINE BESYLATE EQ 2.5MG BASE · TABLET · ORAL

Approval history

2017-10-30Labeling · Supplement 62 · standardLetterAP
2017-03-30Labeling · Supplement 61 · standardLabelAP
2015-03-23Labeling · Supplement 59 · standardLabelAP
2014-07-28Manufacturing (CMC) · Supplement 58 · standardAP
2013-09-12Manufacturing (CMC) · Supplement 56 · standardAP
2013-07-24Manufacturing (CMC) · Supplement 57 · standardAP
2013-01-07Labeling · Supplement 54 · unknownLabelAP
2013-01-07Labeling · Supplement 53 · unknownLabelAP
2012-11-16Manufacturing (CMC) · Supplement 55 · standardAP
2011-10-31Labeling · Supplement 52 · unknownLabelAP
2011-05-09Labeling · Supplement 47 · unknownLetterAP
2010-02-17Labeling · Supplement 45 · standardLetterAP
2007-10-31Labeling · Supplement 42 · standardLabelAP
2005-09-28Efficacy · Supplement 38 · unknownLetterAP
2005-07-13Labeling · Supplement 37 · standardLetterAP
2004-01-08Efficacy · Supplement 30 · standardReviewAP
2003-12-03Labeling · Supplement 27 · standardLetterAP
2003-08-20Labeling · Supplement 31 · standardLetterAP
2002-05-28Labeling · Supplement 32 · standardLetterAP
2001-08-13Manufacturing (CMC) · Supplement 29 · standardAP
2001-08-10Manufacturing (CMC) · Supplement 28 · standardAP
2000-09-06Manufacturing (CMC) · Supplement 24 · standardAP
2000-07-12Efficacy · Supplement 20 · standardReviewAP
2000-07-12Labeling · Supplement 17 · standardLetterAP
2000-03-14Labeling · Supplement 23 · standardAP
2000-02-23Manufacturing (CMC) · Supplement 25 · standardAP
2000-02-01Manufacturing (CMC) · Supplement 21 · standardReviewAP
1999-12-15Manufacturing (CMC) · Supplement 22 · standardReviewAP
1999-09-07Manufacturing (CMC) · Supplement 19 · standardLetterAP
1999-06-04Manufacturing (CMC) · Supplement 18 · standardReviewAP
1998-03-09Manufacturing (CMC) · Supplement 16 · standardReviewAP
1997-05-16Manufacturing (CMC) · Supplement 15 · standardReviewAP
1997-04-18Manufacturing (CMC) · Supplement 14 · standardReviewAP
1997-01-08Labeling · Supplement 13 · standardReviewAP
1996-06-28Manufacturing (CMC) · Supplement 12 · standardReviewAP
1996-06-14Efficacy · Supplement 7 · standardReviewAP
1996-02-08Manufacturing (CMC) · Supplement 10 · standardReviewAP
1996-02-07Manufacturing (CMC) · Supplement 11 · standardReviewAP
1995-12-05Labeling · Supplement 9 · standardReviewAP
1995-11-02Manufacturing (CMC) · Supplement 8 · standardReviewAP
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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