Application 202702

Type: ANDA
Sponsor: STRIDES PHARMA

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	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 table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
64380-746	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-746	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-746	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-746	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-746	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-747	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-747	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-747	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-747	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-747	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-748	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-748	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-748	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-748	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-748	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-749	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-749	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-749	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-749	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-749	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-750	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-750	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-750	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-750	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-750	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-751	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-751	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-751	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-751	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current
64380-751	pramipexole dihydrochloride	pramipexole dihydrochloride	Strides Pharma Science Limited	ANDA	Current

Application 202702

Related Records#

Application Products#

NDC Listings For This Application#