Details for New Drug Application (NDA): 210676

NDA 210676 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 210676

Tradename:	IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	diphenhydramine hydrochloride; ibuprofen
Patents:	0

Pharmacology for NDA: 210676

Mechanism of Action

Cyclooxygenase Inhibitors Histamine H1 Receptor Antagonists

Suppliers and Packaging for NDA: 210676

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	210676	ANDA	Walgreens	0363-0250	0363-0250-40	1 BOTTLE, PLASTIC in 1 BOX (0363-0250-40) / 40 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE	diphenhydramine hydrochloride; ibuprofen	CAPSULE;ORAL	210676	ANDA	Aurohealth LLC	58602-717	58602-717-30	160 CAPSULE, LIQUID FILLED in 1 BOTTLE (58602-717-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	OTC	Dosage:	CAPSULE;ORAL			Strength	25MG;EQ 200MG FREE ACID AND POTASSIUM SALT
Approval Date:	Feb 14, 2019	TE:		RLD:	No

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