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FDA ANDA · ANDA091135

TOPCARE COUGH DM

dextromethorphan polistirex

Sponsor: TRIS PHARMA INC

APPLICATION
ANDA091135
TYPE
ANDA
ORIGINAL APPROVAL
2012-05-25
LATEST ACTION
2014-10-27
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

2014-10-27Manufacturing (CMC) · Supplement 2AP
2012-09-28Manufacturing (CMC) · Supplement 1AP
2012-05-25Original — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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