# DEXEDRINE SPANSULE
> **NDA017078** · New Drug Application · Sponsor: IMPAX LABS INC · Approved 1976-08-02
## Drug
- **FDA Application Number:** NDA017078
- **Application type:** New Drug Application
- **Brand name:** DEXEDRINE SPANSULE
- **Generic name:** DEXTROAMPHETAMINE SULFATE
- **Active ingredients:** DEXTROAMPHETAMINE SULFATE
- **Dosage form:** CAPSULE, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** IMPAX LABS INC
- **Manufacturer:** Amneal Pharmaceuticals LLC
- **First approval:** 1976-08-02
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=017078)
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