Details for New Drug Application (NDA): 216656
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NDA 216656 describes ESTRADIOL VALERATE, which is a drug marketed by Am Regent, Dr Reddys, Fosun Pharma, Hikma, Watson Labs, and Xiromed, and is included in seven NDAs. It is available from three suppliers. Additional details are available on the ESTRADIOL VALERATE profile page.
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.
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 216656
| Tradename: | ESTRADIOL VALERATE |
| Applicant: | Xiromed |
| Ingredient: | estradiol valerate |
| Patents: | 0 |
Pharmacology for NDA: 216656
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 216656
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 216656 | ANDA | Xiromed, LLC | 70700-273 | 70700-273-22 | 5 mL in 1 VIAL, MULTI-DOSE (70700-273-22) |
| ESTRADIOL VALERATE | estradiol valerate | INJECTABLE;INJECTION | 216656 | ANDA | Xiromed, LLC | 70700-274 | 70700-274-22 | 5 mL in 1 VIAL, MULTI-DOSE (70700-274-22) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Apr 28, 2023 | TE: | AO | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
| Approval Date: | Apr 28, 2023 | TE: | AO | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/ML | ||||
| Approval Date: | Apr 28, 2023 | TE: | AO | RLD: | No | ||||
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