Application 207636

Type: ANDA
Sponsor: SOMERSET THERAPS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	20MG/10ML (2MG/ML)	No	No
002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	40MG/20ML (2MG/ML)	No	No
003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	100MG/20ML (5MG/ML)	No	No
004	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/30ML (5MG/ML)	No	No
005	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/20ML (7.5MG/ML)	No	No
006	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	100MG/10ML (10MG/ML)	No	No
007	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	200MG/20ML (10MG/ML)	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
70069-061	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-061	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-061	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-061	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-061	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-061	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-061	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-062	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-062	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-062	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-062	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-062	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-062	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-062	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-063	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-063	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-063	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-063	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-063	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-063	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-063	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-064	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-064	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-064	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-064	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-064	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-064	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-064	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-065	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-065	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-065	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-065	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-065	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-065	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-065	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-066	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-066	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-066	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-066	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-066	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-066	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-066	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-067	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-067	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-067	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-067	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-067	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-067	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current
70069-067	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Somerset Therapeutics, LLC	ANDA	Current

Application 207636

Related Records#

Application Products#

NDC Listings For This Application#