FDA NDC Directory · JSON-LD · Markdown
NDC 35573-464 · HUMAN PRESCRIPTION DRUG · CAPSULE, EXTENDED RELEASE
| Labeler / Manufacturer | Burel Pharmaceuticals, LLC |
|---|---|
| Marketing category | Abbreviated NDA (generic) · App ANDA212037 |
| Dosage form / route | CAPSULE, EXTENDED RELEASE · ORAL |
| Active ingredients | AMPHETAMINE ASPARTATE MONOHYDRATE (1.25 mg/1) AMPHETAMINE SULFATE (1.25 mg/1) DEXTROAMPHETAMINE SACCHARATE (1.25 mg/1) DEXTROAMPHETAMINE SULFATE (1.25 mg/1) |
| Marketing started | 20191216 |
| Marketing ended | 20280229 |
| Package count | 1 |
Source: openFDA. Public-domain (CC0).