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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 210965

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NDA 210965 describes PROGESTERONE, which is a drug marketed by Amneal Pharms Ny, Bionpharma, Dr Reddys, Eugia Pharma, Sofgen Pharms, Teva Pharms, Xiromed, Accord Hlthcare, Actavis Labs Ut Inc, Am Regent, Fresenius Kabi Usa, Hikma Farmaceutica, and Lilly, and is included in sixteen NDAs. It is available from twenty-two suppliers. Additional details are available on the PROGESTERONE profile page.

The generic ingredient in PROGESTERONE is progesterone. There are fifty-seven drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the progesterone profile page.

Summary for 210965

Tradename:	PROGESTERONE
Applicant:	Eugia Pharma
Ingredient:	progesterone
Patents:	0

Pharmacology for NDA: 210965

Medical Subject Heading (MeSH) Categories for 210965

Progestins

Suppliers and Packaging for NDA: 210965

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROGESTERONE	progesterone	INJECTABLE;INJECTION	210965	ANDA	Eugia US LLC	55150-306	55150-306-10	10 mL in 1 VIAL, MULTI-DOSE (55150-306-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Dec 6, 2018	TE:	AO	RLD:	No

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