Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amerigen Pharmaceuticals Inc.. The primary component is Dextroamphetamine Sulfate; Dextroamphetamine Saccharate; Amphetamine Aspartate Monohydrate; Amphetamine Sulfate.
| Product ID | 43975-332_d1a00e02-3bf2-4018-a1cd-9506ab554685 |
| NDC | 43975-332 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine Sulfate |
| Generic Name | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, And Amphetamine Sulfate |
| Dosage Form | Capsule, Extended Release |
| Route of Administration | ORAL |
| Marketing Start Date | 2018-12-03 |
| Marketing Category | NDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC |
| Application Number | NDA021303 |
| Labeler Name | Amerigen Pharmaceuticals Inc. |
| Substance Name | DEXTROAMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE |
| Active Ingredient Strength | 3 mg/1; mg/1; mg/1; mg/1 |
| Pharm Classes | Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE],Central Nervous System Stimulant [EPC],Central Nervous System Stimulation [PE] |
| DEA Schedule | CII |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |