Application 202891

Type: ANDA
Sponsor: ZYDUS PHARMS

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
68382-474	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-474	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-474	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-474	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-475	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-475	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-475	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-475	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-476	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-476	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-476	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-476	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-477	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-477	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-477	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-477	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-478	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-478	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-478	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-478	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-874	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-874	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-874	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-874	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-875	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-875	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-875	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-875	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
70771-1328	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1328	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1328	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1328	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1329	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1329	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1329	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1329	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1330	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1330	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1330	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1330	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1331	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1331	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1331	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1331	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1332	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1332	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1332	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1332	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1333	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1333	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1333	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1333	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Lifesciences Limited	ANDA	Current
70771-1334	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1334	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1334	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Cadila Healthcare Limited	ANDA	Current
70771-1334	Pramipexole Dihydrochloride	Pramipexole Dihydrochloride	Zydus Lifesciences Limited	ANDA	Current

Application 202891

Related Records#

Application Products#

NDC Listings For This Application#