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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 200888


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NDA 200888 describes IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, which is a drug marketed by Aurobindo Pharma Ltd, Bionpharma, and Onesource Specialty, and is included in three NDAs. It is available from fourteen suppliers. Additional details are available on the IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE profile page.

The generic ingredient in IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE is diphenhydramine hydrochloride; ibuprofen. There are twenty-three drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the diphenhydramine hydrochloride; ibuprofen profile page.
Summary for 200888
Tradename:IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:Onesource Specialty
Ingredient:diphenhydramine hydrochloride; ibuprofen
Patents:0
Pharmacology for NDA: 200888
Mechanism of ActionCyclooxygenase Inhibitors
Histamine H1 Receptor Antagonists
Suppliers and Packaging for NDA: 200888
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE diphenhydramine hydrochloride; ibuprofen CAPSULE;ORAL 200888 ANDA TOP CARE (Topco Associates LLC) 36800-756 36800-756-40 1 BOTTLE, PLASTIC in 1 BOX (36800-756-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC

Profile for product number 001

Active Rx/OTC/Discontinued:OTCDosage:CAPSULE;ORALStrength25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date:Mar 5, 2012TE:RLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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