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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 216318

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NDA 216318 describes TESTOSTERONE CYPIONATE, which is a drug marketed by Am Regent, Cipla, Eugia Pharma, Hikma, Hikma Farmaceutica, Padagis Us, Rising, Sandoz, Sun Pharm Inds Ltd, Watson Labs, Watson Pharms Inc, Wilshire Pharms Inc, Xiromed, and Azurity, and is included in sixteen NDAs. It is available from seventeen suppliers. There are two patents protecting this drug. Additional details are available on the TESTOSTERONE CYPIONATE profile page.

The generic ingredient in TESTOSTERONE CYPIONATE is estradiol cypionate; testosterone cypionate. There are seventy-five drug master file entries for this compound. Additional details are available on the estradiol cypionate; testosterone cypionate profile page.

Summary for 216318

Tradename:	TESTOSTERONE CYPIONATE
Applicant:	Azurity
Ingredient:	testosterone cypionate
Patents:	2

Pharmacology for NDA: 216318

Mechanism of Action	Androgen Receptor Agonists

Suppliers and Packaging for NDA: 216318

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TESTOSTERONE CYPIONATE	testosterone cypionate	SOLUTION;INTRAMUSCULAR	216318	NDA	Azurity Pharmaceuticals, Inc.	24338-055	24338-055-01	1 SYRINGE, GLASS in 1 CARTON (24338-055-01) / 1 mL in 1 SYRINGE, GLASS
TESTOSTERONE CYPIONATE	testosterone cypionate	SOLUTION;INTRAMUSCULAR	216318	NDA	Azurity Pharmaceuticals, Inc.	24338-056	24338-056-01	1 VIAL in 1 CARTON (24338-056-01) / 1 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;INTRAMUSCULAR			Strength	200MG/ML (200MG/ML)
Approval Date:	Jun 2, 2022	TE:		RLD:	Yes
Patent:	⤷ Sign Up	Patent Expiration:	Mar 25, 2039	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	⤷ Sign Up	Patent Expiration:	Mar 25, 2039	Product Flag?	Y	Substance Flag?		Delist Request?

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