AMPHETAMINE SULFATE
Amphetamine Sulfate Tablets, USP CII
Approved
Approval ID
85a015a7-a1a0-4b04-8bc4-7aacd0c84742
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2024
Manufacturers
FDA
Lannett Company, Inc.
DUNS: 002277481
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
amphetamine sulfate
PRODUCT DETAILS
NDC Product Code0527-2524
Application NumberANDA212901
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 19, 2024
Generic Nameamphetamine sulfate
INGREDIENTS (5)
AMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
amphetamine sulfate
PRODUCT DETAILS
NDC Product Code0527-2525
Application NumberANDA212901
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 19, 2024
Generic Nameamphetamine sulfate
INGREDIENTS (6)
AMPHETAMINE SULFATEActive
Quantity: 10 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
FD&C BLUE NO. 1--ALUMINUM LAKEInactive
Code: J9EQA3S2JM
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT