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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 075906

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NDA 075906 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 fifteen NDAs. It is available from twenty-one 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 075906

Tradename:	PROGESTERONE
Applicant:	Fresenius Kabi Usa
Ingredient:	progesterone
Patents:	0

Pharmacology for NDA: 075906

Medical Subject Heading (MeSH) Categories for 075906

Progestins

Suppliers and Packaging for NDA: 075906

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROGESTERONE	progesterone	INJECTABLE;INJECTION	075906	ANDA	Fresenius Kabi USA, LLC	63323-261	63323-261-10	1 VIAL, MULTI-DOSE in 1 CARTON (63323-261-10) / 10 mL in 1 VIAL, MULTI-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	50MG/ML
Approval Date:	Apr 25, 2001	TE:	AO	RLD:	No

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