Orange Book product · Generic (ANDA)
DEXTROAMPHETAMINE SULFATE
DEXTROAMPHETAMINE SULFATE
At a glance
Approved Prior to Jan 1, 1982
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
No patent or exclusivity dates are listed for this product.
Pharmaceutical detail
Active ingredient
DEXTROAMPHETAMINE SULFATE
Strength
15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
ANDA 085652
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of DEXTROAMPHETAMINE SULFATE
- —DEXEDRINE SPANSULEBrand (NDA)
NDA 017078 · IMPAX LABS INC
- 2022DEXTROAMPHETAMINE SULFATEGeneric (ANDA)
ANDA 206095 · TRIS PHARMA INC
- 2021DEXTROAMPHETAMINE SULFATEGeneric (ANDA)
ANDA 212160 · WINDER LABS LLC
- 2019DEXTROAMPHETAMINE SULFATEGeneric (ANDA)
ANDA 205077 · STRIDES PHARMA
- 2017DEXTROAMPHETAMINE SULFATEGeneric (ANDA)
ANDA 205673 · STRIDES PHARMA INTL
- 2017DEXTROAMPHETAMINE SULFATEGeneric (ANDA)
ANDA 210059 · NUVO PHARM
- 2017DEXTROAMPHETAMINE SULFATEGeneric (ANDA)
ANDA 209111 · NESHER PHARMS
- 2016DEXTROAMPHETAMINE SULFATEGeneric (ANDA)
ANDA 206588 · NESHER PHARMS
- 2016DEXTROAMPHETAMINE SULFATEGeneric (ANDA)
ANDA 204330 · NOVEL LABS INC
- 2016DEXTROAMPHETAMINE SULFATEGeneric (ANDA)
ANDA 206735 · QUAGEN
- 2015DEXTROAMPHETAMINE SULFATEGeneric (ANDA)
ANDA 203548 · AVANTHI INC
- 2014DEXTROAMPHETAMINE SULFATEGeneric (ANDA)
ANDA 090652 · EPIC PHARMA LLC
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
