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DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2026-06-03

Drug application

FDA Application #
ANDA204196
Application type
Abbreviated New Drug Application (Generic)
Brand name
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE
Generic name
DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATE
Active ingredients
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
Dosage form
CAPSULE
Route
ORAL
Marketing status
Prescription
Sponsor
SUN PHARM
Manufacturer
Sun Pharmaceutical Industries, Inc.
First approval
2026-06-03

Source

Authoritative
Drugs@FDA application overview
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