Details for New Drug Application (NDA): 209767
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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.
Pharmacology for NDA: 209767
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 209767
Suppliers and Packaging for NDA: 209767
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | estradiol | CREAM;VAGINAL | 209767 | ANDA | Alvogen Inc. | 47781-104 | 47781-104-44 | 1 TUBE, WITH APPLICATOR in 1 CARTON (47781-104-44) / 42.5 g in 1 TUBE, WITH APPLICATOR |
ESTRADIOL | estradiol | CREAM;VAGINAL | 209767 | ANDA | A-S Medication Solutions | 50090-3645 | 50090-3645-0 | 1 TUBE, WITH APPLICATOR in 1 CARTON (50090-3645-0) / 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: | Mar 5, 2018 | TE: | AB | RLD: | No |
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