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Last Updated: October 31, 2024

Details for New Drug Application (NDA): 212659


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NDA 212659 describes TESTOSTERONE ENANTHATE, which is a drug marketed by Eugia Pharma, Hikma Farmaceutica, Nexus, Rising, Watson Labs, and Watson Pharms Inc, and is included in nine NDAs. It is available from two suppliers. Additional details are available on the TESTOSTERONE ENANTHATE profile page.

The generic ingredient in TESTOSTERONE ENANTHATE is estradiol valerate; testosterone enanthate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol valerate; testosterone enanthate profile page.
Summary for 212659
Tradename:TESTOSTERONE ENANTHATE
Applicant:Eugia Pharma
Ingredient:testosterone enanthate
Patents:0
Pharmacology for NDA: 212659
Mechanism of ActionAndrogen Receptor Agonists
Suppliers and Packaging for NDA: 212659
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TESTOSTERONE ENANTHATE testosterone enanthate INJECTABLE;INJECTION 212659 ANDA Eugia US LLC 55150-336 55150-336-01 1 VIAL, MULTI-DOSE in 1 CARTON (55150-336-01) / 5 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200MG/ML
Approval Date:Feb 28, 2024TE:AORLD:No

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