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Last Updated: June 16, 2021

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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. 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 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:AORLD: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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2021, www.DrugPatentWatch.com.

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