Orange Book product · Generic (ANDA)
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
At a glance
Sep 09, 2003
Approved
Generic (ANDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 09, 2003
23 yr 1 mo ago
Today
Pharmaceutical detail
Active ingredient
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Strength
1.25MG;1.25MG;1.25MG;1.25MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
ANDA 040480
Product number
001
Marketing status
RX
Reference listed drug (RLD)
No
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
- 2017MYDAYISBrand (NDA)
NDA 022063 · TAKEDA PHARMS USA
- 2001ADDERALL XR 10Brand (NDA)
NDA 021303 · TAKEDA PHARMS USA
- 1996ADDERALL 10Brand (NDA)
NDA 011522 · TEVA WOMENS
- 2024DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEGeneric (ANDA)
ANDA 214777 · LUPIN
- 2023DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEGeneric (ANDA)
ANDA 217787 · ALKEM LABS LTD
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ANDA 215997 · SUN PHARM INDS INC
- 2023DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEGeneric (ANDA)
ANDA 211546 · SPECGX LLC
- 2023DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEGeneric (ANDA)
ANDA 217027 · GRANULES
- 2022DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEGeneric (ANDA)
ANDA 215565 · LANNETT CO INC
- 2022DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEGeneric (ANDA)
ANDA 210754 · CEDIPROF INC
- 2022DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEGeneric (ANDA)
ANDA 210876 · TEVA PHARMS USA
- 2021DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEGeneric (ANDA)
ANDA 215771 · GRANULES
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.
