Last Updated: September 28, 2026

Details for New Drug Application (NDA): 217707

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NDA 217707 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 217707

Tradename:	PROGESTERONE
Applicant:	Accord Hlthcare
Ingredient:	progesterone
Patents:	0

Medical Subject Heading (MeSH) Categories for 217707

Progestins

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Nov 21, 2023	TE:	AO	RLD:	No

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