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Drug Product Composition: Estradiol Acetate

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USFDA APPLICATION NUMBER - 21367 / DOSAGE - INSERT, EXTENDED RELEASE;VAGINAL - EQ 0.1MG BASE/24HR

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL ACETATE(UNII: 5R97F5H93P)
(ESTRADIOL - UNII:4TI98Z838E)
ESTRADIOL0.1mg in 1 | 0.05mg in 1

Inactive Ingredients

Ingredient Name
Allergan, Inc.
BARIUM SULFATE(25BB7EKE2E)
DIATOMACEOUS EARTH(2RF6EJ0M85)
DIMETHICONE(92RU3N3Y1O)
STANNOUS 2-ETHYLHEXANOATE(519A78R12Y)
TETRAPROPYL ORTHOSILICATE(4PE821G3GH)