← FDA DRUG APPROVALS
FDA ANDA · ANDA091632
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX EXTENDED-RELEASE
hydrocodone polistirex and chlorpheniramine polistirex
Sponsor: TRIS PHARMA INC
APPLICATION
ANDA091632
TYPE
ANDA
ORIGINAL APPROVAL
2010-10-01
LATEST ACTION
2017-12-27
ROUTE
ORAL
DOSAGE FORM
SUSPENSION, EXTENDED RELEASE
MARKETING STATUS
Prescription
Products
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREXPrescription
CHLORPHENIRAMINE POLISTIREX EQ 8MG MALEATE/5ML, HYDROCODONE POLISTIREX EQ 10MG BITARTRATE/5ML · SUSPENSION, EXTENDED RELEASE · ORAL
Approval history
2017-12-27Labeling · Supplement 17 · standardAP
2017-12-27Manufacturing (CMC) · Supplement 5AP
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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