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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-2524
Application NumberANDA212901
Product Classification
M
Marketing Category
C73584
G
Generic Name
amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2024
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0527-2525
Application NumberANDA212901
Product Classification
M
Marketing Category
C73584
G
Generic Name
amphetamine sulfate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2024
FDA Product Classification
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