Details for New Drug Application (NDA): 210194
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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 210194
Tradename: | ESTRADIOL |
Applicant: | Padagis Israel |
Ingredient: | estradiol |
Patents: | 0 |
Pharmacology for NDA: 210194
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 210194
Suppliers and Packaging for NDA: 210194
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | estradiol | CREAM;VAGINAL | 210194 | ANDA | AvKARE | 42291-426 | 42291-426-42 | 1 TUBE in 1 CARTON (42291-426-42) / 42.5 g in 1 TUBE |
ESTRADIOL | estradiol | CREAM;VAGINAL | 210194 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-097 | 45802-097-35 | 1 TUBE in 1 CARTON (45802-097-35) / 42.5 g in 1 TUBE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | CREAM;VAGINAL | Strength | 0.01% | ||||
Approval Date: | Jan 22, 2018 | TE: | AB | RLD: | No |
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