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FDA ANDA · ANDA202934

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

Sponsor: ACTAVIS ELIZABETH

APPLICATION
ANDA202934
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-10
LATEST ACTION
2023-05-24
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATEPrescription
DEXTROMETHORPHAN HYDROBROMIDE 20MG, QUINIDINE SULFATE 10MG · CAPSULE · ORAL

Approval history

2023-05-24Labeling · Supplement 1 · standardAP
2017-10-10UNKNOWN · Original — Letter ↗AP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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