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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 017362

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NDA 017362 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 017362

Tradename:	PROGESTERONE
Applicant:	Actavis Labs Ut Inc
Ingredient:	progesterone
Patents:	0

Pharmacology for NDA: 017362

Medical Subject Heading (MeSH) Categories for 017362

Progestins

Suppliers and Packaging for NDA: 017362

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROGESTERONE	progesterone	INJECTABLE;INJECTION	017362	NDA	Actavis Pharma, Inc.	0591-3128	0591-3128-79	10 mL in 1 VIAL, MULTI-DOSE (0591-3128-79)

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Approved Prior to Jan 1, 1982	TE:		RLD:	Yes

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