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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 200456

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NDA 200456 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 200456

Tradename:	PROGESTERONE
Applicant:	Sofgen Pharms
Ingredient:	progesterone
Patents:	0

Pharmacology for NDA: 200456

Medical Subject Heading (MeSH) Categories for 200456

Progestins

Suppliers and Packaging for NDA: 200456

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROGESTERONE	progesterone	CAPSULE;ORAL	200456	ANDA	Hikma Pharmaceuticals USA Inc	0054-0829	0054-0829-25	100 CAPSULE in 1 BOTTLE (0054-0829-25)
PROGESTERONE	progesterone	CAPSULE;ORAL	200456	ANDA	Hikma Pharmaceuticals USA Inc	0054-0830	0054-0830-25	100 CAPSULE in 1 BOTTLE (0054-0830-25)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	100MG
Approval Date:	Sep 28, 2012	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	200MG
Approval Date:	Sep 28, 2012	TE:	AB	RLD:	No

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