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DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ALKEM LABS LTD · Approved 2023-10-06
Drug application
- FDA Application #
ANDA217787- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
- Generic name
- Amphetamine Aspartate
- Active ingredients
- AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE
- Dosage form
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ALKEM LABS LTD
- First approval
- 2023-10-06
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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