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Details for New Drug Application (NDA): 022113

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NDA 022113 describes ADVIL ALLERGY AND CONGESTION RELIEF, which is a drug marketed by Pfizer and is included in one NDA. It is available from one supplier. Additional details are available on the ADVIL ALLERGY AND CONGESTION RELIEF profile page.

The generic ingredient in ADVIL ALLERGY AND CONGESTION RELIEF is chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride profile page.

Summary for NDA: 022113

Suppliers and Packaging for NDA: 022113

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL ALLERGY AND CONGESTION RELIEF
chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride
TABLET;ORAL 022113 NDA Pfizer Consumer Healthcare 0573-0196 0573-0196-01 50 PACKET in 1 TRAY (0573-0196-01) > 1 TABLET, COATED in 1 PACKET
ADVIL ALLERGY AND CONGESTION RELIEF
chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride
TABLET;ORAL 022113 NDA Pfizer Consumer Healthcare 0573-0196 0573-0196-10 1 BLISTER PACK in 1 CARTON (0573-0196-10) > 10 TABLET, COATED in 1 BLISTER PACK

Summary for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength4MG;200MG;10MG
Approval Date:Dec 21, 2011TE:RLD:Yes


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