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FDA NDA · NDA020472

ESTRING

estradiol

Sponsor: PFIZER

APPLICATION
NDA020472
TYPE
NDA
ORIGINAL APPROVAL
1996-04-26
LATEST ACTION
2026-02-12
ROUTE
VAGINAL
DOSAGE FORM
INSERT, EXTENDED RELEASE
MARKETING STATUS
Prescription

Products

ESTRING · ReferencePrescription
ESTRADIOL 0.0075MG/24HR · INSERT, EXTENDED RELEASE · VAGINAL

Approval history

2026-02-12Labeling · Supplement 22 · standard — Label ↗AP
2024-02-15Labeling · Supplement 20 · standard — Letter ↗AP
2022-07-27Labeling · Supplement 19 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 16 · standard — Label ↗AP
2015-09-29Labeling · Supplement 12 · standard — Label ↗AP
2015-09-29Labeling · Supplement 13 · standard — Letter ↗AP
2014-08-12Labeling · Supplement 11 · standard — Letter ↗AP
2014-05-16Manufacturing (CMC) · Supplement 10 · standardAP
2008-08-25Labeling · Supplement 7 · standard — Letter ↗AP
2001-07-24Manufacturing (CMC) · Supplement 4 · standard — Review ↗AP
2000-05-16Labeling · Supplement 1 · standard — Review ↗AP
2000-01-05Labeling · Supplement 3 · standard — Review ↗AP
1997-04-18Manufacturing (CMC) · Supplement 2 · standardAP
1996-04-26Type 3 - New Dosage Form · 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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