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
Feb 16, 2016
Approved
Generic (ANDA)
Application
AB1
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 16, 2016
10 yr 6 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
CAPSULE, EXTENDED RELEASE
Route
ORAL
TE code
AB1
Application
ANDA 076852
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
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- 1996ADDERALL 10Brand (NDA)
NDA 011522 · TEVA WOMENS
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ANDA 217787 · ALKEM LABS LTD
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ANDA 215997 · SUN PHARM INDS INC
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ANDA 211546 · SPECGX LLC
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ANDA 217027 · GRANULES
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ANDA 215565 · LANNETT CO INC
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ANDA 210754 · CEDIPROF INC
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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.
