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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

10b6135f-226e-4422-8048-c4bb74d9719a

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Mar 2, 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 Code63629-2382
Application NumberANDA209799
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJuly 24, 2017
Generic Namedextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate

INGREDIENTS (9)

AMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: 6DPV8NK46S
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DEXTROAMPHETAMINE SULFATEActive
Quantity: 5 mg in 1 1
Code: JJ768O327N
Classification: ACTIB
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

Drug Labeling Information

DESCRIPTION SECTION

LOINC: 34089-3Updated: 7/25/2017

DESCRIPTION

A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate.

** EACH TABLET CONTAINS**

5 mg

7.5 mg

10 mg

12.5 mg

15 mg

20 mg

30 mg

Dextroamphetamine Saccharate

1.25 mg

1.875 mg

2.5 mg

3.125 mg

3.75 mg

5 mg

7.5 mg

Amphetamine Aspartate Monohydrate

1.25 mg

1.875 mg

2.5 mg

3.125 mg

3.75 mg

5 mg

7.5 mg

Dextroamphetamine Sulfate, USP

1.25 mg

1.875 mg

2.5 mg

3.125 mg

3.75 mg

5 mg

7.5 mg

Amphetamine Sulfate, USP

1.25 mg

1.875 mg

2.5 mg

3.125 mg

3.75 mg

5 mg

7.5 mg

Total Amphetamine Base Equivalence

3.13 mg

4.7 mg

6.3 mg

7.8 mg

9.4 mg

12.6 mg

18.8 mg

**Inactive Ingredients:**colloidal silicon dioxide, magnesium stearate, microcrystalline cellulose and pregelatinized starch (botanical source: maize).

Colors:

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) 5 mg, 7.5 mg and 10 mg also contain FD&C Blue #1 Aluminum Lake as a color additive.

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Amphetamine Product) 12.5 mg, 15 mg, 20 mg and 30 mg also contain FD&C Yellow #6 Aluminum Lake as a color additive.

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DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE - FDA Approval | MedPath