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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 218391

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NDA 218391 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 218391

Tradename:	PROGESTERONE
Applicant:	Xiromed
Ingredient:	progesterone
Patents:	0

Pharmacology for NDA: 218391

Medical Subject Heading (MeSH) Categories for 218391

Progestins

Suppliers and Packaging for NDA: 218391

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROGESTERONE	progesterone	INSERT;VAGINAL	218391	ANDA	XIROMED, LLC	70700-201	70700-201-70	1 CARTON in 1 CARTON (70700-201-70) / 21 BLISTER PACK in 1 CARTON (70700-201-69) / 1 INSERT in 1 BLISTER PACK (70700-201-68)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INSERT;VAGINAL			Strength	100MG
Approval Date:	Sep 19, 2025	TE:	AB	RLD:	No
Regulatory Exclusivity Expiration:	Mar 22, 2026
Regulatory Exclusivity Use:	COMPETITIVE GENERIC THERAPY

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