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FDA ANDA · ANDA203839
HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Sponsor: TRIS PHARMA INC
APPLICATION
ANDA203839
TYPE
ANDA
ORIGINAL APPROVAL
2014-10-28
LATEST ACTION
2014-10-28
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
2014-10-28UNKNOWN · OriginalAP
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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