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Last Updated: May 1, 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
Formulation / Manufacturing:	see details

Pharmacology for NDA: 212659

Mechanism of Action	Androgen 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:	RX	Dosage:	INJECTABLE;INJECTION			Strength	200MG/ML
Approval Date:	Feb 28, 2024	TE:	AO	RLD:	No

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