← FDA Drug Approvals (Drugs@FDA)
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ELITE LABS INC · Approved 2018-12-07
Drug application
- FDA Application #
ANDA211352- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
- Generic name
- DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE AND AMPHETAMINE SULFATE
- Active ingredients
- AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ELITE LABS INC
- Manufacturer
- Elite Laboratories, Inc.
- First approval
- 2018-12-07
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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