← FDA Drug Approvals (Drugs@FDA)

DEXTROMETHORPHAN POLISTIREX

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TRIS PHARMA INC · Approved 2012-05-25

Drug application

FDA Application #
ANDA091135
Application type
Abbreviated New Drug Application (Generic)
Brand name
DEXTROMETHORPHAN POLISTIREX
Generic name
DEXTROMETHORPHAN POLISTIREX
Active ingredients
DEXTROMETHORPHAN POLISTIREX
Dosage form
SUSPENSION, EXTENDED RELEASE
Route
ORAL
Marketing status
Over-the-counter
Sponsor
TRIS PHARMA INC
Manufacturer
Topco Associates LLC
First approval
2012-05-25

Source

Authoritative
Drugs@FDA application overview
Machine
JSON-LD · Markdown