Details for New Drug Application (NDA): 217334
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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 217334
Tradename: | ESTRADIOL |
Applicant: | Novitium Pharma |
Ingredient: | estradiol |
Patents: | 0 |
Pharmacology for NDA: 217334
Mechanism of Action | Estrogen Receptor Agonists |
Medical Subject Heading (MeSH) Categories for 217334
Suppliers and Packaging for NDA: 217334
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRADIOL | estradiol | TABLET;ORAL | 217334 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-3629 | 68071-3629-3 | 30 TABLET in 1 BOTTLE (68071-3629-3) |
ESTRADIOL | estradiol | TABLET;ORAL | 217334 | ANDA | NuCare Pharmaceuticals,Inc. | 68071-3689 | 68071-3689-9 | 100 TABLET in 1 BOTTLE (68071-3689-9) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
Approval Date: | Sep 6, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
Approval Date: | Sep 6, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
Approval Date: | Sep 6, 2023 | TE: | AB | RLD: | No |
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