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 27, 2023
Approved
Generic (ANDA)
Application
AB2
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 27, 2023
2 yr 9 mo ago
Today
Pharmaceutical detail
Active ingredient
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
Strength
3.125MG;3.125MG;3.125MG;3.125MG
Dosage form
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB2
Application
ANDA 215997
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
- 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
- 2021DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATEGeneric (ANDA)
ANDA 214403 · LANNETT CO INC
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.
