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FDA ANDA · ANDA206438
HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE
Sponsor: TRIS PHARMA INC
APPLICATION
ANDA206438
TYPE
ANDA
ORIGINAL APPROVAL
2015-01-27
LATEST ACTION
2015-01-27
ROUTE
ORAL
DOSAGE FORM
SOLUTION
MARKETING STATUS
Discontinued
Products
HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATEDiscontinued
CHLORPHENIRAMINE MALEATE 4MG/5ML, HYDROCODONE BITARTRATE 5MG/5ML · SOLUTION · ORAL
Approval history
2015-01-27UNKNOWN · Original · standardAP
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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