Application 078894

Type: ANDA
Sponsor: ALEMBIC 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
46708-003	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-004	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-005	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-006	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-007	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-611	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-612	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-613	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-614	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-615	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
62332-003	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-003	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-003	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-003	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-003	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-004	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-004	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-004	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-004	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-004	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-005	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-005	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-005	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-005	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-005	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-006	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-006	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-006	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-006	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-006	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-007	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-007	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-007	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-007	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-007	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current

Application 078894

Related Records#

Application Products#

NDC Listings For This Application#