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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 021374


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NDA 021374 describes ADVIL COLD AND SINUS, which is a drug marketed by Haleon Us Holdings and is included in two NDAs. It is available from one supplier. Additional details are available on the ADVIL COLD AND SINUS profile page.

The generic ingredient in ADVIL COLD AND SINUS 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.
Summary for 021374
Pharmacology for NDA: 021374
Suppliers and Packaging for NDA: 021374
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 021374 NDA Haleon US Holdings LLC 0573-0184 0573-0184-16 16 BLISTER PACK in 1 CARTON (0573-0184-16) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK
ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 021374 NDA Haleon US Holdings LLC 0573-0184 0573-0184-32 32 BLISTER PACK in 1 CARTON (0573-0184-32) / 1 CAPSULE, LIQUID FILLED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrengthEQ 200MG FREE ACID AND POTASSIUM SALT;30MG
Approval Date:May 30, 2002TE:RLD:Yes

Expired US Patents for NDA 021374

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Haleon Us Holdings ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 021374-001 May 30, 2002 ⤷  Sign Up ⤷  Sign Up
Haleon Us Holdings ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride CAPSULE;ORAL 021374-001 May 30, 2002 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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