← FDA Drug Approvals (Drugs@FDA)
DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: COREPHARMA · Approved 2016-04-15
Drug application
- FDA Application #
ANDA206304- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
- Generic name
- Dextroamphetamine Saccharate
- Active ingredients
- DEXTROAMPHETAMINE SACCHARATE; AMPHETAMINE ASPARTATE MONOHYDRATE; DEXTROAMPHETAMINE SULFATE; AMPHETAMINE SULFATE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- COREPHARMA
- First approval
- 2016-04-15
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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