Orange Book product · Generic (ANDA)
AMPHETAMINE SULFATE
AMPHETAMINE SULFATE
At a glance
Aug 31, 1984
Approved
Generic (ANDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 31, 1984
42 yr 5 mo ago
Today
Pharmaceutical detail
Active ingredient
AMPHETAMINE SULFATE
Strength
5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 083901
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyGeneric (ANDA) of AMPHETAMINE SULFATE
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ANDA 213852 · RHODES PHARMS
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ANDA 212186 · GLENMARK PHARMS LTD
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ANDA 214574 · SUN PHARM INDS INC
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ANDA 213583 · SPECGX LLC
- 2020AMPHETAMINE SULFATEGeneric (ANDA)
ANDA 213720 · ALKEM LABS LTD
- 2020AMPHETAMINE SULFATEGeneric (ANDA)
ANDA 213980 · EPIC PHARMA LLC
- 2020AMPHETAMINE SULFATEGeneric (ANDA)
ANDA 213763 · INGENUS PHARMS LLC
- 2020AMPHETAMINE SULFATEGeneric (ANDA)
ANDA 213898 · DR REDDYS LABS SA
- 2020AMPHETAMINE SULFATEGeneric (ANDA)
ANDA 212901 · SENORES PHARMS
- 2020AMPHETAMINE SULFATEGeneric (ANDA)
ANDA 211861 · PRINSTON INC
- 2020AMPHETAMINE SULFATEGeneric (ANDA)
ANDA 212582 · SANALUZ
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.
