Details for New Drug Application (NDA): 203723
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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 203723
Tradename: | ESTRADIOL VALERATE |
Applicant: | Hikma |
Ingredient: | estradiol valerate |
Patents: | 0 |
Pharmacology for NDA: 203723
Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 203723
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 203723 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9289 | 0143-9289-01 | 1 VIAL in 1 CARTON (0143-9289-01) / 5 mL in 1 VIAL |
ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 203723 | ANDA | Hikma Pharmaceuticals USA Inc. | 0143-9290 | 0143-9290-01 | 1 VIAL in 1 CARTON (0143-9290-01) / 5 mL in 1 VIAL |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
Approval Date: | Apr 21, 2020 | TE: | AO | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
Approval Date: | Apr 21, 2020 | TE: | AO | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/ML | ||||
Approval Date: | Apr 21, 2020 | TE: | AO | RLD: | No |
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