Application 202633

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

Related Records

Company: AUROBINDO PHARMA LTD

Application Products

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	Labeler	Marketing category	Status
50090-2455	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-2455	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-2455	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-2455	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3280	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3280	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3280	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3280	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3280	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3280	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-3280	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-5036	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-5036	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
50090-5036	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	A-S Medication Solutions	ANDA	Current
57237-180	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-180	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-180	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-180	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-181	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-181	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-181	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-181	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-182	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-182	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-182	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-182	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-183	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-183	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-183	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-183	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-184	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-184	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-184	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-184	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-185	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-185	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-185	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
57237-185	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Rising Health, LLC	ANDA	Current
63629-8289	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-8289	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
65862-604	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-604	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-604	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-604	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-604	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-605	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-605	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-605	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-605	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-605	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-606	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-606	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-606	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-606	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-606	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-607	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-607	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-607	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-607	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-607	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-608	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-608	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-608	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-608	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-608	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-609	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-609	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-609	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-609	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
65862-609	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Aurobindo Pharma Limited	ANDA	Current
71335-1504	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1504	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1537	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1537	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1808	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1808	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1877	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Bryant Ranch Prepack	ANDA	Current
71335-1877	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Bryant Ranch Prepack	ANDA	Current