FDA ANDA · ANDA220432
LORATADINE AND PSEUDOEPHEDRINE SULFATE
Sponsor: DR REDDYS
What this page does not claim
A drug page is a reference view of public FDA data (Drugs@FDA), reproduced as published. SPEQ is not affiliated with the FDA, adds no interpretation to the record, and nothing here is medical, legal, or regulatory advice.
APPLICATION
ANDA220432
TYPE
ANDA
ORIGINAL APPROVAL
2026-10-16
LATEST ACTION
2026-10-16
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter
Products
LORATADINE AND PSEUDOEPHEDRINE SULFATEOver-the-counter
LORATADINE 10MG, PSEUDOEPHEDRINE SULFATE 240MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-10-16UNKNOWN · Original · standardAP
Source: FDA Drugs@FDA. Browse every approval SPEQ tracks →