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DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS ELIZABETH · Approved 2017-10-10
Drug application
- FDA Application #
ANDA202934- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
- Generic name
- Dextromethorphan Hydrobromide
- Active ingredients
- DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
- Dosage form
- CAPSULE
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ACTAVIS ELIZABETH
- First approval
- 2017-10-10
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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