Details for New Drug Application (NDA): 009402
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NDA 009402 describes DELESTROGEN, which is a drug marketed by Par Sterile Products and is included in one NDA. It is available from one supplier. Additional details are available on the DELESTROGEN profile page.
The generic ingredient in DELESTROGEN 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 DELESTROGEN 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 009402
| Tradename: | DELESTROGEN |
| Applicant: | Par Sterile Products |
| Ingredient: | estradiol valerate |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 009402
| Mechanism of Action | Estrogen Receptor Agonists |
Suppliers and Packaging for NDA: 009402
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DELESTROGEN | estradiol valerate | INJECTABLE;INJECTION | 009402 | NDA | Par Pharmaceutical, Inc. | 42023-110 | 42023-110-01 | 5 mL in 1 VIAL, MULTI-DOSE (42023-110-01) |
| DELESTROGEN | estradiol valerate | INJECTABLE;INJECTION | 009402 | NDA | Par Pharmaceutical, Inc. | 42023-111 | 42023-111-01 | 5 mL in 1 VIAL, MULTI-DOSE (42023-111-01) |
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 10MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AO | RLD: | Yes | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 40MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AO | RLD: | Yes | ||||
Profile for product number 004
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 20MG/ML | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AO | RLD: | Yes | ||||
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