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Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

These highlights do not include all the information needed to use Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules (MAS-ER) safely and effectively. See full prescribing information for MAS-ER Capsules. Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate and Amphetamine Sulfate Extended-Release Capsules (mixed salts of a single-entity amphetamine product), CII Initial U.S. Approval: 2001

Approved
Approval ID

34726042-2386-4c19-abec-440769fff99a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 12, 2015

Manufacturers
FDA

Global Pharmaceuticals, Division of Impax Laboratories Inc.

DUNS: 116732830

Products 6

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 Code0115-1330
Application NumberNDA021303
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateMay 14, 2015
Generic NameDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

INGREDIENTS (12)

DEXTROAMPHETAMINE SULFATEActive
Quantity: 3.75 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 3.75 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
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

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

NDC Product Code0115-1331
Application NumberNDA021303
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateMay 14, 2015
Generic NameDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

INGREDIENTS (13)

TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 5 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 5 mg in 1 1
Code: G83415V073
Classification: ACTIB

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

NDC Product Code0115-1328
Application NumberNDA021303
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateMay 14, 2015
Generic NameDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

INGREDIENTS (12)

GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 1.25 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 1.25 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 1.25 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 1.25 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

NDC Product Code0115-1333
Application NumberNDA021303
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateMay 14, 2015
Generic NameDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

INGREDIENTS (13)

DEXTROAMPHETAMINE SULFATEActive
Quantity: 7.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 7.5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 7.5 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 7.5 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

NDC Product Code0115-1329
Application NumberNDA021303
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateMay 14, 2015
Generic NameDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

INGREDIENTS (12)

DEXTROAMPHETAMINE SULFATEActive
Quantity: 2.5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
AMPHETAMINE SULFATEActive
Quantity: 2.5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 2.5 mg in 1 1
Code: G83415V073
Classification: ACTIB
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 2.5 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

PRODUCT DETAILS

NDC Product Code0115-1332
Application NumberNDA021303
Marketing CategoryC73605
Route of AdministrationORAL
Effective DateMay 14, 2015
Generic NameDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate

INGREDIENTS (13)

DEXTROAMPHETAMINE SULFATEActive
Quantity: 6.25 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
AMPHETAMINE SULFATEActive
Quantity: 6.25 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UM
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)Inactive
Code: 74G4R6TH13
Classification: IACT
AMPHETAMINE ASPARTATE MONOHYDRATEActive
Quantity: 6.25 mg in 1 1
Code: O1ZPV620O4
Classification: ACTIB
DEXTROAMPHETAMINE SACCHARATEActive
Quantity: 6.25 mg in 1 1
Code: G83415V073
Classification: ACTIB

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Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate - FDA Drug Approval Details