Details for New Drug Application (NDA): 085470
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NDA 085470 describes DEPO-ESTRADIOL, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the DEPO-ESTRADIOL profile page.
The generic ingredient in DEPO-ESTRADIOL is estradiol cypionate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol cypionate profile page.
The generic ingredient in DEPO-ESTRADIOL is estradiol cypionate. There are seventy-five drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the estradiol cypionate profile page.
Summary for 085470
| Tradename: | DEPO-ESTRADIOL |
| Applicant: | Pfizer |
| Ingredient: | estradiol cypionate |
| Patents: | 0 |
Pharmacology for NDA: 085470
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 085470
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DEPO-ESTRADIOL | estradiol cypionate | INJECTABLE;INJECTION | 085470 | ANDA | Pharmacia & Upjohn Company LLC | 0009-0271 | 0009-0271-01 | 1 VIAL in 1 CARTON (0009-0271-01) / 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 1MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | INJECTABLE;INJECTION | Strength | 3MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 5MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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