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Last Updated: July 16, 2020

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Details for New Drug Application (NDA): 021393

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NDA 021393 describes ADVIL PM, which is a drug marketed by Glaxosmithkline and is included in two NDAs. It is available from four 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. Thirty-one suppliers are listed for this compound. Additional details are available on the diphenhydramine citrate; ibuprofen profile page.
Summary for 021393
Tradename:ADVIL PM
Applicant:Glaxosmithkline
Ingredient:diphenhydramine hydrochloride; ibuprofen
Patents:2
Suppliers and Packaging for NDA: 021393
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393 NDA Pfizer Consumer Healthcare 0573-0167 0573-0167-25 1 BOTTLE in 1 CARTON (0573-0167-25) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
ADVIL PM diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 021393 NDA Pfizer Consumer Healthcare 0573-0167 0573-0167-26 1 BOTTLE in 1 CARTON (0573-0167-26) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE
Paragraph IV (Patent) Challenges for 021393
Tradename Dosage Ingredient NDA Submissiondate
ADVIL PM CAPSULE;ORAL diphenhydramine hydrochloride; ibuprofen 021393 2016-02-16

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date:Dec 21, 2005TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Jan 17, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:A METHOD OF TREATING A PATIENT SUFFERING FROM A PAIN ASSOCIATED SLEEP DISTURBANCE COMPRISING ADMINISTERING A LIQUID COMPOSITION FORMULATED INSIDE A SOFT GEL CAPSULE, AS CLAIMED, TO THE PATIENT
Patent:  Start TrialPatent Expiration:Jan 17, 2022Product Flag?YSubstance Flag?Delist Request?

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