Amphetamine Sulfate
Amphetamine Sulfate Tablets, USP CII
Approved
Approval ID
26dbad66-13c4-4906-88b3-ab7ee191466c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 16, 2023
Manufacturers
FDA
Granules Pharmaceuticals Inc.
DUNS: 079825711
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 Code70010-041
Application NumberANDA212619
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 16, 2023
Generic NameAmphetamine Sulfate
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 10 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Amphetamine Sulfate
PRODUCT DETAILS
NDC Product Code70010-040
Application NumberANDA212619
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateOctober 16, 2023
Generic NameAmphetamine Sulfate
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT