← FDA DRUG APPROVALS

FDA NDA · NDA021367

FEMRING

estradiol acetate

Sponsor: MILLICENT MFG PR

APPLICATION
NDA021367
TYPE
NDA
ORIGINAL APPROVAL
2003-03-20
LATEST ACTION
2024-02-15
ROUTE
VAGINAL
DOSAGE FORM
INSERT, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

FEMRING · ReferencePrescription
ESTRADIOL ACETATE EQ 0.05MG BASE/24HR · INSERT, EXTENDED RELEASE · VAGINAL
FEMRING · ReferencePrescription
ESTRADIOL ACETATE EQ 0.1MG BASE/24HR · INSERT, EXTENDED RELEASE · VAGINAL

Approval history

2024-02-15Labeling · Supplement 21 · standard — Letter ↗AP
2023-08-18Labeling · Supplement 20 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 16 · standard — Letter ↗AP
2017-08-08Labeling · Supplement 15 · standard — Label ↗AP
2017-08-08Labeling · Supplement 14 · standard — Label ↗AP
2014-05-29Labeling · Supplement 13 · standard — Letter ↗AP
2009-05-20Labeling · Supplement 9 · standard — Label ↗AP
2007-02-14Labeling · Supplement 7 · standard — Letter ↗AP
2005-08-16Labeling · Supplement 5 · standard — Label ↗AP
2005-03-11Labeling · Supplement 2 · standard — Label ↗AP
2003-03-20Type 2 - New Active Ingredient · Original · standard — Letter ↗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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