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DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PAR PHARM INC · Approved 2015-12-23

Drug application

FDA Application #

ANDA202993

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

None (Tentative Approval)

Sponsor

PAR PHARM INC

First approval

2015-12-23

Source

Authoritative

Drugs@FDA application overview

Machine

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