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FDA ANDA · ANDA210264
ESTRADIOL VAGINAL INSERTS
estradiol
Sponsor: GLENMARK PHARMS LTD
APPLICATION
ANDA210264
TYPE
ANDA
ORIGINAL APPROVAL
2018-09-14
LATEST ACTION
2024-08-30
ROUTE
VAGINAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ESTRADIOLPrescription
ESTRADIOL 10MCG · TABLET · VAGINAL
Approval history
2024-08-30Labeling · Supplement 9 · standardAP
2024-08-30Labeling · Supplement 7 · standardAP
2024-08-30Labeling · Supplement 4 · standardAP
2021-02-17Labeling · Supplement 1 · standardAP
2018-09-14UNKNOWN · 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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