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Last Updated: October 21, 2021

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Details for New Drug Application (NDA): 021394

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NDA 021394 describes ADVIL PM, which is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from three suppliers. There are three patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ADVIL PM profile page.

The generic ingredient in ADVIL PM is diphenhydramine citrate; ibuprofen. There are twenty-three drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.
Summary for 021394
Tradename:ADVIL PM
Ingredient:diphenhydramine citrate; ibuprofen
Suppliers and Packaging for NDA: 021394
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL PM diphenhydramine citrate; ibuprofen TABLET;ORAL 021394 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0573-0164 0573-0164-04 4 TABLET, COATED in 1 POUCH (0573-0164-04)
ADVIL PM diphenhydramine citrate; ibuprofen TABLET;ORAL 021394 NDA GlaxoSmithKline Consumer Healthcare Holdings (US) LLC 0573-0164 0573-0164-05 2 BOTTLE in 1 CARTON (0573-0164-05) > 2 TABLET, COATED in 1 BOTTLE
Paragraph IV (Patent) Challenges for 021394
Tradename Dosage Ingredient NDA Submissiondate
ADVIL PM TABLET;ORAL diphenhydramine citrate; ibuprofen 021394 2017-12-28

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:TABLET;ORALStrength38MG;200MG
Approval Date:Dec 21, 2005TE:RLD:Yes
Patent:⤷  Try it FreePatent Expiration:May 30, 2022Product Flag?YSubstance Flag?Delist Request?

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