← FDA DRUG APPROVALS

FDA NDA · NDA020907

LOPREEZA

estradiol/norethindrone acetate

Sponsor: AMNEAL

APPLICATION
NDA020907
TYPE
NDA
ORIGINAL APPROVAL
1998-11-18
LATEST ACTION
2024-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription, Discontinued

Products

ACTIVELLA · ReferencePrescription
ESTRADIOL 1MG, NORETHINDRONE ACETATE 0.5MG · TABLET · ORAL
ACTIVELLA · ReferenceDiscontinued
ESTRADIOL 0.5MG, NORETHINDRONE ACETATE 0.1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · TABLET · ORAL

Approval history

2024-02-15Labeling · Supplement 30 · standard — Letter ↗AP
2021-08-10Labeling · Supplement 22 · standard — Letter ↗AP
2021-08-10Labeling · Supplement 20 · standard — Letter ↗AP
2020-04-06Manufacturing (CMC) · Supplement 25 — Label ↗AP
2017-11-01Labeling · Supplement 19 · standard — Label ↗AP
2016-05-27Manufacturing (CMC) · Supplement 16 · standardAP
2015-01-12Manufacturing (CMC) · Supplement 15 · standardAP
2013-10-08Labeling · Supplement 13 · standard — Label ↗AP
2006-12-28Efficacy · Supplement 9 · unknown — Letter ↗AP
2006-12-28Labeling · Supplement 11 · standard — Letter ↗AP
2005-06-30Labeling · Supplement 5 · standard — Letter ↗AP
2004-07-26Supplement · Supplement 7 · standard — Review ↗AP
2002-09-13Manufacturing (CMC) · Supplement 6 · standard — Review ↗AP
2000-11-14Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
2000-04-11Labeling · Supplement 3 · standard — Review ↗AP
2000-02-10Labeling · Supplement 2 · standard — Review ↗AP
1999-11-03Manufacturing (CMC) · Supplement 1 · standard — Review ↗AP
1998-11-18Type 4 - New Combination · Original · standard — Review ↗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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