Application 206156

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, EXTENDED RELEASE;ORAL	0.375MG	No	No
002	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	0.75MG	No	No
003	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	1.5MG	No	No
004	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	2.25MG	No	No
005	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	3MG	No	No
006	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	4.5MG	No	No
007	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	3.75MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
16714-916	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-916	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-916	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-916	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-916	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-917	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-917	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-917	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-917	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-917	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-918	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-918	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-918	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-918	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-918	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-919	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-919	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-919	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-919	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-919	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-920	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-920	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-920	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-920	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-920	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-921	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-921	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-921	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-921	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-922	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-922	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-922	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-922	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
16714-922	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	NorthStar RxLLC	ANDA	Current
33342-208	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-208	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-208	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-208	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-208	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-209	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-209	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-209	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-209	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-209	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-210	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-210	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-210	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-210	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-210	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-211	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-211	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-211	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-211	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-211	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-212	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-212	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-212	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-212	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-212	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-213	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-213	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-213	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-213	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-213	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-214	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-214	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-214	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-214	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current
33342-214	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Macleods Pharmaceuticals Limited	ANDA	Current

Application 206156

Related Records#

Application Products#

NDC Listings For This Application#