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FDA ANDA · ANDA203133

DEXTROMETHORPHAN POLISTIREX EXTENDED-RELEASE

dextromethorphan polistirex

Sponsor: AMNEAL

APPLICATION
ANDA203133
TYPE
ANDA
ORIGINAL APPROVAL
2017-07-28
LATEST ACTION
2017-07-28
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

DEXTROMETHORPHAN POLISTIREXOver-the-counter
DEXTROMETHORPHAN POLISTIREX EQ 30MG HYDROBROMIDE/5ML · SUSPENSION, EXTENDED RELEASE · ORAL

Approval history

2017-07-28UNKNOWN · OriginalReviewAP
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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