Application 020701

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	CRINONE	PROGESTERONE	GEL;VAGINAL	4%	Yes	Yes
002	CRINONE	PROGESTERONE	GEL;VAGINAL	8%	Yes	Yes

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0023-6150	Crinone	progesterone	Allergan, Inc.	NDA	Current
0023-6151	Crinone	progesterone	Allergan, Inc.	NDA	Current
52544-255	Crinone	progesterone	Actavis Pharma, Inc.	NDA	Current
52544-256	Crinone	progesterone	Actavis Pharma, Inc.	NDA	Current
55056-0406	Prochieve	progesterone	Columbia Laboratories	NDA	Current
55056-0806	Crinone	progesterone	Columbia Laboratories, Inc.	NDA	Current
55056-0808	Crinone	progesterone	Columbia Laboratories, Inc.	NDA	Current
55056-0818	Crinone	progesterone	Columbia Laboratories, Inc.	NDA	Current
55056-1601	Prochieve	progesterone	Columbia Laboratories	NDA	Current