DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) CII
Approved
Approval ID
dff226eb-0ec4-498a-b660-a67e57ea2030
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 8, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
PRODUCT DETAILS
NDC Product Code63629-2378
Application NumberANDA209799
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 24, 2017
Generic Namedextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate
INGREDIENTS (9)
DEXTROAMPHETAMINE SULFATEActive
Quantity: 3.75 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 3.75 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 3.75 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 3.75 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB