← FDA DRUG APPROVALS
FDA ANDA · ANDA091671
HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX
Sponsor: NEOS THERAPS INC
APPLICATION
ANDA091671
TYPE
ANDA
ORIGINAL APPROVAL
2012-06-29
LATEST ACTION
2015-11-20
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Discontinued
Products
HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREXDiscontinued
CHLORPHENIRAMINE POLISTIREX EQ 8MG MALEATE/5ML, HYDROCODONE POLISTIREX EQ 10MG BITARTRATE/5ML · SUSPENSION, EXTENDED RELEASE · ORAL
Approval history
2015-11-20Manufacturing (CMC) · Supplement 5 · unknownAP
2012-06-29OriginalAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.