Application 090781

Type: ANDA
Sponsor: GLENMARK GENERICS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.125MG	No	No
002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.25MG	No	No
003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.5MG	No	No
004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1MG	No	No
005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1.5MG	No	No
006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	0.75MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-2190	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-2190	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-2190	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-2217	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
68462-330	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-330	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-330	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-330	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-331	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-331	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-331	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-331	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-332	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-332	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-332	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-332	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-333	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-333	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-333	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-333	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-334	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-334	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-334	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-334	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-627	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-627	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-627	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
68462-627	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Glenmark Pharmaceuticals Inc., USA	ANDA	Current
70934-596	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Denton Pharma, Inc. dba Northwind Pharmaceuticals	ANDA	Current

Application 090781

Related Records#

Application Products#

NDC Listings For This Application#