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FDA ANDA · ANDA205658

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor: MAYNE PHARMA INC

APPLICATION
ANDA205658
TYPE
ANDA
ORIGINAL APPROVAL
2015-11-17
LATEST ACTION
2015-11-17
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued

Products

HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDEDiscontinued
HYDROCODONE BITARTRATE 5MG/5ML, PSEUDOEPHEDRINE HYDROCHLORIDE 60MG/5ML · SOLUTION · ORAL

Approval history

2015-11-17UNKNOWN · Original · standardAP
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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