← FDA DRUG APPROVALS

FDA ANDA · ANDA086069

ESTRADIOL

Sponsor: ABBVIE

APPLICATION
ANDA086069
TYPE
ANDA
ORIGINAL APPROVAL
1984-01-31
LATEST ACTION
2024-02-15
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription

Products

ESTRACE · ReferencePrescription
ESTRADIOL 0.01% · CREAM · VAGINAL

Approval history

2024-02-15Labeling · Supplement 27 · standardAP
2022-11-30Labeling · Supplement 26 · standard — Letter ↗AP
2018-08-15Labeling · Supplement 24 · standardAP
2017-06-21Labeling · Supplement 23 · standardAP
2005-08-17Labeling · Supplement 18 — Label ↗AP
2001-03-27Manufacturing (CMC) · Supplement 17 — Review ↗AP
2000-08-11Labeling · Supplement 16AP
2000-08-11Manufacturing (CMC) · Supplement 15AP
1998-08-03Labeling · Supplement 12AP
1997-09-09Manufacturing (CMC) · Supplement 11AP
1996-12-31Labeling · Supplement 10AP
1994-01-14Manufacturing (CMC) · Supplement 9AP
1992-09-23Labeling · Supplement 8AP
1992-03-11Labeling · Supplement 5AP
1991-06-07Labeling · Supplement 7AP
1987-10-16Manufacturing (CMC) · Supplement 3AP
1986-07-17Manufacturing (CMC) · Supplement 2AP
1984-01-31OriginalAP
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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