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Generated: November 21, 2018

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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. 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 009402
Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen 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:RXDosage:INJECTABLE;INJECTIONStrength10MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength40MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:AORLD:Yes

Profile for product number 004

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength20MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:AORLD:Yes

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