Last Updated: November 8, 2026

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, Lilly, and Glenmark Pharms, and is included in seventeen NDAs. It is available from twenty-five suppliers. Additional details are available on the PROGESTERONE profile page.

The generic ingredient in PROGESTERONE is progesterone. There is one drug master file entry for this compound. Twenty-nine 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

Medical Subject Heading (MeSH) Categories for 017362

Progestins

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Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons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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