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Generated: June 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 085470

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NDA 085470 describes DEPO-ESTRADIOL, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from two suppliers. 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. Two suppliers are listed for this compound. Additional details are available on the estradiol cypionate profile page.
Summary for 085470
Tradename:DEPO-ESTRADIOL
Applicant:Pharmacia And Upjohn
Ingredient:estradiol cypionate
Patents:0
Therapeutic Class:Hormonal Agents, Stimulant/Replacement/Modifying (Sex Hormones/Modifiers)
Formulation / Manufacturing:see details
Pharmacology for NDA: 085470
Ingredient-typeEstradiol Congeners
Mechanism of ActionEstrogen 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 and Upjohn Company LLC 0009-0271 N 0009-0271-01
DEPO-ESTRADIOL estradiol cypionate INJECTABLE;INJECTION 085470 ANDA Physicians Total Care, Inc. 54868-1729 E 54868-1729-0

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength1MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength3MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength5MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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