DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLETS CII
Approved
Approval ID
f55aba1f-9404-4a49-8e3b-7a66ce538c60
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 25, 2010
Manufacturers
FDA
STAT RX USA LLC
DUNS: 786036330
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 SUFLATE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16590-901
Application NumberANDA040422
Product Classification
M
Marketing Category
C73584
G
Generic Name
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SUFLATE
Product Specifications
Route of AdministrationORAL
Effective DateJune 25, 2010
FDA Product Classification
INGREDIENTS (10)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 7.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 7.5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
COLLOIDAL SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 7.5 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATEActive
Quantity: 7.5 mg in 1 1
Code: H527KAP6L5
Classification: ACTIB