Application 202164

Type: ANDA
Sponsor: MACLEODS PHARMS 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	1MG	No	No
005	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
33342-031	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-031	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-032	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-032	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-033	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-033	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-034	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-034	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-035	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-035	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
50090-2676	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3350	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3350	Pramipexole dihydrochloride	Pramipexole dihydrochloride	A-S Medication Solutions	ANDA	Current
63629-8105	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1112	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1185	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1185	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1196	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1196	Pramipexole dihydrochloride	Pramipexole dihydrochloride	Bryant Ranch Prepack	ANDA	Current