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Last Updated: November 25, 2024

Details for New Drug Application (NDA): 213565


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NDA 213565 describes IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma, Perrigo, Aurobindo Pharma Ltd, Contract Pharmacal, and Dr Reddys Labs Ltd, and is included in five NDAs. It is available from five suppliers. Additional details are available on the IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE profile page.

The generic ingredient in IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE is ibuprofen; pseudoephedrine hydrochloride. There are sixty-four drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the ibuprofen; pseudoephedrine hydrochloride profile page.
Pharmacology for NDA: 213565
Suppliers and Packaging for NDA: 213565
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 213565 ANDA Aurohealth LLC 58602-839 58602-839-13 4 BLISTER PACK in 1 CARTON (58602-839-13) / 8 TABLET, COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength200MG;30MG
Approval Date:Mar 10, 2023TE:RLD:No

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