Details for New Drug Application (NDA): 210264
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The generic ingredient in ESTRADIOL is estradiol valerate. There are seventy-five drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the estradiol valerate profile page.
Summary for 210264
Tradename: | ESTRADIOL |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | estradiol |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 210264
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210264
Suppliers and Packaging for NDA: 210264
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | estradiol | TABLET;VAGINAL | 210264 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-711 | 68462-711-71 | 8 APPLICATOR in 1 CARTON (68462-711-71) / 1 TABLET, FILM COATED in 1 APPLICATOR |
ESTRADIOL | estradiol | TABLET;VAGINAL | 210264 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-711 | 68462-711-88 | 18 APPLICATOR in 1 CARTON (68462-711-88) / 1 TABLET, FILM COATED in 1 APPLICATOR |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;VAGINAL | Strength | 10MCG | ||||
Approval Date: | Sep 14, 2018 | TE: | AB | RLD: | No |
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