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Last Updated: December 16, 2025

Details for New Drug Application (NDA): 085635


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NDA 085635 describes DEPO-TESTOSTERONE, which is a drug marketed by Pfizer and is included in one NDA. It is available from three suppliers. Additional details are available on the DEPO-TESTOSTERONE profile page.

The generic ingredient in DEPO-TESTOSTERONE is testosterone cypionate. There are sixty-nine drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the testosterone cypionate profile page.
Summary for 085635
Tradename:DEPO-TESTOSTERONE
Applicant:Pfizer
Ingredient:testosterone cypionate
Patents:0
Pharmacology for NDA: 085635
Mechanism of ActionAndrogen Receptor Agonists
Suppliers and Packaging for NDA: 085635
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
DEPO-TESTOSTERONE testosterone cypionate INJECTABLE;INJECTION 085635 ANDA Pharmacia & Upjohn Company LLC 0009-0085 0009-0085-10 1 VIAL in 1 CARTON (0009-0085-10) / 10 mL in 1 VIAL
DEPO-TESTOSTERONE testosterone cypionate INJECTABLE;INJECTION 085635 ANDA Pharmacia & Upjohn Company LLC 0009-0086 0009-0086-01 1 VIAL in 1 CARTON (0009-0086-01) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength50MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength100MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:AORLD:Yes

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Approved Prior to Jan 1, 1982TE:AORLD:Yes

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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