APPLICATION
ANDA209767
TYPE
ANDA
ORIGINAL APPROVAL
2018-03-05
LATEST ACTION
2024-02-16
ROUTE
VAGINAL
DOSAGE FORM
CREAM
MARKETING STATUS
Prescription
Products
ESTRADIOLPrescription
ESTRADIOL 0.01% · CREAM · VAGINAL
Approval history
2024-02-16Labeling · Supplement 13 · standardAP
2024-01-29Labeling · Supplement 11 · standardAP
2018-08-15Labeling · Supplement 1 · standardAP
2018-03-05UNKNOWN · 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.
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