Details for New Drug Application (NDA): 090920
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The generic ingredient in ESTRADIOL VALERATE 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 090920
Tradename: | ESTRADIOL VALERATE |
Applicant: | Am Regent |
Ingredient: | estradiol valerate |
Patents: | 0 |
Pharmacology for NDA: 090920
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 090920
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 090920 | ANDA | American Regent, Inc. | 0517-0420 | 0517-0420-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0420-01) / 5 mL in 1 VIAL, MULTI-DOSE |
ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 090920 | ANDA | American Regent, Inc. | 0517-0440 | 0517-0440-01 | 1 VIAL, MULTI-DOSE in 1 CARTON (0517-0440-01) / 5 mL in 1 VIAL, MULTI-DOSE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
Approval Date: | Jan 19, 2010 | TE: | AO | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/ML | ||||
Approval Date: | Jan 19, 2010 | TE: | AO | RLD: | No |
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