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 Lannett Company, Inc.. The primary component is Dextroamphetamine Saccharate; Dextroamphetamine Sulfate; Amphetamine Aspartate Monohydrate; Amphetamine Sulfate.
| Product ID | 0527-5513_2f5fae05-6e77-4992-8c87-264b98ccf84d |
| NDC | 0527-5513 |
| 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 | 2019-12-18 |
| Marketing Category | ANDA / ANDA |
| Application Number | ANDA212037 |
| Labeler Name | Lannett Company, Inc. |
| Substance Name | DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE |
| Active Ingredient Strength | 5 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 | 2021-12-31 |