← FDA Drug Approvals (Drugs@FDA)
DEXEDRINE SPANSULE
NDA · New Drug Application · Sponsor: IMPAX LABS INC · Approved 1976-08-02
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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