Application 204518

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, 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	3.75MG	No	No
007	PRAMIPEXOLE DIHYDROCHLORIDE	PRAMIPEXOLE DIHYDROCHLORIDE	TABLET, EXTENDED RELEASE;ORAL	4.5MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
46708-574	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-575	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-576	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-577	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-578	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-579	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
46708-580	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Limited	ANDA	Current
62332-154	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-154	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-154	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-155	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-155	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-155	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-156	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-156	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-156	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-157	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-157	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-157	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-158	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-158	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-158	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-159	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-159	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-159	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-160	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-160	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current
62332-160	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Alembic Pharmaceuticals Inc.	ANDA	Current

Application 204518

Related Records#

Application Products#

NDC Listings For This Application#