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FDA NDA · NDA021813

ELESTRIN

estradiol

Sponsor: VIATRIS

APPLICATION
NDA021813
TYPE
NDA
ORIGINAL APPROVAL
2006-12-15
LATEST ACTION
2024-02-15
ROUTE
TOPICAL, TRANSDERMAL
DOSAGE FORM
GEL, METERED
MARKETING STATUS
Prescription

Products

ELESTRIN · ReferencePrescription
ESTRADIOL 0.06% (0.87GM/ACTIVATION) · GEL, METERED · TRANSDERMAL

Approval history

2024-02-15Labeling · Supplement 14 · standard — Letter ↗AP
2020-10-27Labeling · Supplement 7 · standard — Label ↗AP
2020-10-27Labeling · Supplement 9 · standard — Label ↗AP
2017-11-01Labeling · Supplement 6 · standard — Label ↗AP
2014-02-27Manufacturing (CMC) · Supplement 4 · standard — Label ↗AP
2012-02-24Labeling · Supplement 3 · unknown — Label ↗AP
2008-02-26Manufacturing (CMC) · Supplement 1 — Letter ↗AP
2006-12-15Type 5 - New Formulation or New Manufacturer · 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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