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Generated: November 17, 2018

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Details for New Drug Application (NDA): 201803

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NDA 201803 describes ADVIL, which is a drug marketed by Pfizer and Pfizer Cons Hlthcare and is included in ten NDAs. It is available from four suppliers. There are four patents protecting this drug and three Paragraph IV challenges. Additional details are available on the ADVIL profile page.

The generic ingredient in ADVIL is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.
Summary for 201803
Tradename:ADVIL
Applicant:Pfizer Cons Hlthcare
Ingredient:ibuprofen sodium
Patents:0
Formulation / Manufacturing:see details
Suppliers and Packaging for NDA: 201803
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL ibuprofen sodium TABLET;ORAL 201803 NDA Wyeth Consumer Healthcare LLC 0573-0133 0573-0133-01 3000 PACKET in 1 CASE (0573-0133-01) > 2 TABLET, COATED in 1 PACKET
ADVIL ibuprofen sodium TABLET;ORAL 201803 NDA Wyeth Consumer Healthcare LLC 0573-0133 0573-0133-02 50 PACKET in 1 TRAY (0573-0133-02) > 2 TABLET, COATED in 1 PACKET

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrengthEQ 200MG BASE
Approval Date:Jun 12, 2012TE:RLD:Yes

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