← FDA Drug Approvals (Drugs@FDA)
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2023-01-23
Drug application
- FDA Application #
ANDA217027- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
- Generic name
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Active ingredients
- AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- GRANULES
- Manufacturer
- Granules Pharmaceuticals Inc.
- First approval
- 2023-01-23
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown