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Details for New Drug Application (NDA): 009402
The generic ingredient in DELESTROGEN is estradiol valerate. There are seventy-five drug master file entries for this compound. Two 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 |
Therapeutic Class: | Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers) |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 009402
Ingredient-type | Estradiol Congeners |
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 | N | 42023-110-01 |
DELESTROGEN | estradiol valerate | INJECTABLE;INJECTION | 009402 | NDA | Par Pharmaceutical, Inc. | 42023-111 | N | 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: | 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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