APPLICATION
ANDA210488
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-30
LATEST ACTION
2024-02-15
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
ESTRADIOLPrescription
ESTRADIOL 0.01% · CREAM · VAGINAL
Approval history
2024-02-15Labeling · Supplement 3 · standardAP
2018-08-09Labeling · Supplement 1 · standardAP
2018-03-30UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.