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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 091033

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NDA 091033 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 091033

Tradename:	PROGESTERONE
Applicant:	Hikma Farmaceutica
Ingredient:	progesterone
Patents:	0

Pharmacology for NDA: 091033

Medical Subject Heading (MeSH) Categories for 091033

Progestins

Suppliers and Packaging for NDA: 091033

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROGESTERONE	progesterone	INJECTABLE;INJECTION	091033	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9725	0143-9725-01	10 INJECTION in 1 BOX (0143-9725-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Oct 28, 2010	TE:	AO	RLD:	No

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