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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70010-041
Application NumberANDA212619
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70010-040
Application NumberANDA212619
Product Classification
M
Marketing Category
C73584
G
Generic Name
Amphetamine Sulfate
Product Specifications
Route of AdministrationORAL
Effective DateOctober 16, 2023
FDA Product Classification
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