FDA NDC Directory · JSON-LD · Markdown
NDC 54092-474 · HUMAN PRESCRIPTION DRUG · CAPSULE, EXTENDED RELEASE
| Generic name | DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, and AMPHETAMINE SULFATE |
|---|---|
| Labeler / Manufacturer | Takeda Pharmaceuticals America, Inc. |
| Marketing category | New Drug Application (innovator) · App NDA022063 |
| Dosage form / route | CAPSULE, EXTENDED RELEASE · ORAL |
| Active ingredients | AMPHETAMINE ASPARTATE MONOHYDRATE (9.375 mg/1) AMPHETAMINE SULFATE (9.375 mg/1) DEXTROAMPHETAMINE SACCHARATE (9.375 mg/1) DEXTROAMPHETAMINE SULFATE (9.375 mg/1) |
| Marketing started | 20170620 |
| Package count | 1 |
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