DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE

DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE TABLET Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets CII Rx only

Approved

Approval ID

430cccec-1679-4225-8c86-92d746153b38

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Sep 28, 2023

Manufacturers

FDA

Camber Pharmaceuticals, Inc.

DUNS: 826774775

Products 7

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 Code31722-155

Application NumberANDA213709

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateSeptember 28, 2023

Generic Namedextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

INGREDIENTS (11)

AMPHETAMINE SULFATEActive

Quantity: 1.25 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

DEXTROAMPHETAMINE SULFATEActive

Quantity: 1.25 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TY

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 1.25 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 1.25 mg in 1 1

Code: G83415V073

Classification: ACTIB

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

PRODUCT DETAILS

NDC Product Code31722-164

Application NumberANDA213709

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateSeptember 28, 2023

Generic Namedextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

INGREDIENTS (12)

AMPHETAMINE SULFATEActive

Quantity: 7.5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

DEXTROAMPHETAMINE SULFATEActive

Quantity: 7.5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TY

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 7.5 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 7.5 mg in 1 1

Code: G83415V073

Classification: ACTIB

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

PRODUCT DETAILS

NDC Product Code31722-159

Application NumberANDA213709

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateSeptember 28, 2023

Generic Namedextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

INGREDIENTS (12)

AMPHETAMINE SULFATEActive

Quantity: 3.75 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

DEXTROAMPHETAMINE SULFATEActive

Quantity: 3.75 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TY

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SUCROSEInactive

Code: C151H8M554

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 Code31722-156

Application NumberANDA213709

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateSeptember 28, 2023

Generic Namedextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

INGREDIENTS (12)

AMPHETAMINE SULFATEActive

Quantity: 1.875 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

DEXTROAMPHETAMINE SULFATEActive

Quantity: 1.875 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

SACCHARIN SODIUMInactive

Code: SB8ZUX40TY

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 1.875 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 1.875 mg in 1 1

Code: G83415V073

Classification: ACTIB

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

PRODUCT DETAILS

NDC Product Code31722-157

Application NumberANDA213709

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateSeptember 28, 2023

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

AMPHETAMINE SULFATEActive

Quantity: 2.5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TY

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

FD&C BLUE NO. 2Inactive

Code: L06K8R7DQK

Classification: IACT

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 2.5 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 2.5 mg in 1 1

Code: G83415V073

Classification: ACTIB

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

PRODUCT DETAILS

NDC Product Code31722-163

Application NumberANDA213709

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateSeptember 28, 2023

Generic Namedextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

INGREDIENTS (12)

SACCHARIN SODIUMInactive

Code: SB8ZUX40TY

Classification: IACT

AMPHETAMINE SULFATEActive

Quantity: 5 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

DEXTROAMPHETAMINE SULFATEActive

Quantity: 5 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

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 Code31722-158

Application NumberANDA213709

Marketing CategoryC73584

Route of AdministrationORAL

Effective DateSeptember 28, 2023

Generic Namedextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

INGREDIENTS (12)

DEXTROAMPHETAMINE SULFATEActive

Quantity: 3.125 mg in 1 1

Code: JJ768O327N

Classification: ACTIB

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61U

Classification: IACT

MALTODEXTRINInactive

Code: 7CVR7L4A2D

Classification: IACT

STARCH, CORNInactive

Code: O8232NY3SJ

Classification: IACT

SACCHARIN SODIUMInactive

Code: SB8ZUX40TY

Classification: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4

Classification: IACT

SUCROSEInactive

Code: C151H8M554

Classification: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30

Classification: IACT

FD&C YELLOW NO. 6Inactive

Code: H77VEI93A8

Classification: IACT

AMPHETAMINE SULFATEActive

Quantity: 3.125 mg in 1 1

Code: 6DPV8NK46S

Classification: ACTIB

AMPHETAMINE ASPARTATE MONOHYDRATEActive

Quantity: 3.125 mg in 1 1

Code: O1ZPV620O4

Classification: ACTIB

DEXTROAMPHETAMINE SACCHARATEActive

Quantity: 3.125 mg in 1 1

Code: G83415V073

Classification: ACTIB

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DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE

Products 7

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

PRODUCT DETAILS

INGREDIENTS (11)

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

PRODUCT DETAILS

INGREDIENTS (12)

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

PRODUCT DETAILS

INGREDIENTS (12)

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

PRODUCT DETAILS

INGREDIENTS (12)

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

PRODUCT DETAILS

INGREDIENTS (12)

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

PRODUCT DETAILS

INGREDIENTS (12)

dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate

PRODUCT DETAILS

INGREDIENTS (12)

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