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FDA ANDA · ANDA218426

DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULFATE

Sponsor: HETERO LABS LTD III

APPLICATION
ANDA218426
TYPE
ANDA
ORIGINAL APPROVAL
2024-08-28
LATEST ACTION
2024-08-28
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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

Approval history

2024-08-28UNKNOWN · Original · standardAP
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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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