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FDA NDA · NDA021371

ESTRASORB

Sponsor: EXELTIS USA INC

APPLICATION
NDA021371
TYPE
NDA
ORIGINAL APPROVAL
2003-10-09
LATEST ACTION
2024-09-10
ROUTE
TOPICAL
DOSAGE FORM
EMULSION
MARKETING STATUS
Discontinued

Products

ESTRASORB · ReferenceDiscontinued
ESTRADIOL HEMIHYDRATE 0.25% · EMULSION · TOPICAL

Approval history

2024-09-10Labeling · Supplement 9 · standard — Letter ↗AP
2024-02-15Labeling · Supplement 10 · standard — Letter ↗AP
2017-11-01Labeling · Supplement 8 · standard — Label ↗AP
2015-03-10Labeling · Supplement 7 · standard — Letter ↗AP
2003-10-09Type 3 - New Dosage Form · Original · standard — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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