Application 212808

Type: ANDA
Sponsor: CAPLIN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	40MG/20ML (2MG/ML)	No	No
002	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	100MG/20ML (5MG/ML)	No	No
003	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	150MG/30ML (5MG/ML)	No	No
004	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	200MG/20ML (10MG/ML)	No	No
005	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	200MG/100ML (2MG/ML)	No	No
006	ROPIVACAINE HYDROCHLORIDE	ROPIVACAINE HYDROCHLORIDE	SOLUTION;INJECTION	400MG/200ML (2MG/ML)	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43066-015	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-015	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-015	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-015	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-019	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-019	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-019	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-019	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-023	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-023	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-023	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-023	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-027	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-027	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-027	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
43066-027	ROPIVACAINE HYDROCHLORIDE	ropivacaine hydrochloride	Baxter Healthcare Corporation	ANDA	Current
65145-107	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Caplin Steriles Limited	ANDA	Current
65145-108	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Caplin Steriles Limited	ANDA	Current
65145-109	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Caplin Steriles Limited	ANDA	Current
65145-110	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Caplin Steriles Limited	ANDA	Current
72572-707	Ropivacaine Hydrochloride	Ropivacaine Hydrochloride	Civica, Inc.	ANDA	Current

Application 212808

Related Records#

Application Products#

NDC Listings For This Application#