← FDA DRUG APPROVALS

FDA NDA · NDA021316

ALTOPREV

Sponsor: AZURITY

APPLICATION
NDA021316
TYPE
NDA
ORIGINAL APPROVAL
2002-06-26
LATEST ACTION
2024-03-14
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Discontinued

Products

ALTOPREV · ReferenceDiscontinued
LOVASTATIN 40MG · TABLET, EXTENDED RELEASE · ORAL
ALTOPREVDiscontinued
LOVASTATIN 10MG · TABLET, EXTENDED RELEASE · ORAL
ALTOPREV · ReferenceDiscontinued
LOVASTATIN 60MG · TABLET, EXTENDED RELEASE · ORAL
ALTOPREV · ReferenceDiscontinued
LOVASTATIN 20MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2024-03-14Labeling · Supplement 37 · standard — Label ↗AP
2020-09-25Labeling · Supplement 36 · 901 required — Letter ↗AP
2018-02-28Labeling · Supplement 35 · standard — Label ↗AP
2017-08-04Labeling · Supplement 34 · standard — Label ↗AP
2015-09-14Manufacturing (CMC) · Supplement 33 · standardAP
2015-05-18Manufacturing (CMC) · Supplement 32 · standardAP
2014-04-30Labeling · Supplement 31 · standard — Letter ↗AP
2013-05-15Manufacturing (CMC) · Supplement 30 · standardAP
2012-12-21Labeling · Supplement 28 · unknown — Letter ↗AP
2012-10-31Labeling · Supplement 29 · 901 required — Label ↗AP
2012-04-26Labeling · Supplement 26 · unknown — Label ↗AP
2007-02-01Labeling · Supplement 18 · standard — Letter ↗AP
2004-07-21Labeling · Supplement 10 · standard — Letter ↗AP
2003-09-24Labeling · Supplement 6 · standard — Label ↗AP
2003-08-20Labeling · Supplement 5 · standard — Letter ↗AP
2002-12-18Manufacturing (CMC) · Supplement 4 · standardAP
2002-09-11Efficacy · Supplement 1 · standard — Letter ↗AP
2002-06-26Type 3 - New Dosage Form · Original · standard — Letter ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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