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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 019771


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NDA 019771 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 019771
Pharmacology for NDA: 019771
Suppliers and Packaging for NDA: 019771
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 019771 NDA Haleon US Holdings LLC 0573-0180 0573-0180-10 2 BLISTER PACK in 1 CARTON (0573-0180-10) / 10 TABLET, COATED in 1 BLISTER PACK
ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 019771 NDA Haleon US Holdings LLC 0573-0180 0573-0180-21 4 BLISTER PACK in 1 CARTON (0573-0180-21) / 10 TABLET, COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength200MG;30MG
Approval Date:Sep 19, 1989TE:RLD:Yes

Expired US Patents for NDA 019771

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Haleon Us Holdings ADVIL COLD AND SINUS ibuprofen; pseudoephedrine hydrochloride TABLET;ORAL 019771-001 Sep 19, 1989 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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