Details for New Drug Application (NDA): 086069
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The generic ingredient in ESTRACE is estradiol. There are seventy-five drug master file entries for this compound. Forty-nine suppliers are listed for this compound. Additional details are available on the estradiol profile page.
Pharmacology for NDA: 086069
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 086069
Suppliers and Packaging for NDA: 086069
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRACE | estradiol | CREAM;VAGINAL | 086069 | ANDA | Teva Pharmaceuticals USA, Inc. | 0093-3541 | 0093-3541-43 | 1 TUBE, WITH APPLICATOR in 1 CARTON (0093-3541-43) / 42.5 g in 1 TUBE, WITH APPLICATOR |
ESTRACE | estradiol | CREAM;VAGINAL | 086069 | ANDA | Allergan, Inc. | 0430-3754 | 0430-3754-14 | 36 CARTON in 1 CASE (0430-3754-14) / 1 TUBE, WITH APPLICATOR in 1 CARTON / 42.5 g in 1 TUBE, WITH APPLICATOR |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;VAGINAL | Strength | 0.01% | ||||
Approval Date: | Jan 31, 1984 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 086069
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | ESTRACE | estradiol | CREAM;VAGINAL | 086069-001 | Jan 31, 1984 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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