Application 207011

Type: ANDA
Sponsor: UNICHEM LABS LTD

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	0.75MG	No	No
005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1MG	No	No
006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET;ORAL	1.5MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
29300-207	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-207	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-207	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-207	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-207	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-207	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-208	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-208	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-208	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-208	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-208	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-208	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-209	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-209	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-209	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-209	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-209	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-209	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-210	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-210	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-210	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-210	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-210	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-210	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-211	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-211	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-211	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-211	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-211	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-211	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-270	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-270	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-270	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-270	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-270	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current
29300-270	pramipexole dihydrochloride	pramipexole dihydrochloride	Unichem Pharmaceuticals (USA), Inc.	ANDA	Current

Application 207011

Related Records#

Application Products#

NDC Listings For This Application#