Application 212160

Type: ANDA
Sponsor: WINDER LABS LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	2.5MG	No	No
002	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	5MG	No	No
003	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	7.5MG	No	No
004	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	10MG	No	No
005	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	15MG	No	No
006	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	20MG	No	No
007	DEXTROAMPHETAMINE SULFATE	DEXTROAMPHETAMINE SULFATE	TABLET;ORAL	30MG	No	No

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
75826-120	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-120	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-120	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-120	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-121	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-121	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-121	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-121	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-122	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-122	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-122	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-122	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-123	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-123	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-123	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-123	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-124	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-124	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-124	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-124	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-125	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-125	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-125	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-125	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-126	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-126	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-126	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current
75826-126	Dextroamphetamine Sulfate	Dextroamphetamine Sulfate	Winder Laboratories LLC	ANDA	Current

Application 212160

Related Records#

Application Products#

NDC Listings For This Application#