➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
Mallinckrodt
Medtronic
McKinsey
Baxter

Last Updated: October 21, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021394


Email this page to a colleague

« Back to Dashboard

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
Applicant:Glaxosmithkline
Ingredient:diphenhydramine citrate; ibuprofen
Patents:1
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?

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Dow
Medtronic
Harvard Business School
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.