Last Updated: May 10, 2026

Details for New Drug Application (NDA): 219538

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NDA 219538 describes IBUPROFEN AND FAMOTIDINE, which is a drug marketed by Alkem Labs Ltd, Ascent Pharms Inc, Aurobindo Pharma Ltd, Ph Health, Teva Pharms Usa, Torrent, and Zydus Lifesciences, and is included in seven NDAs. It is available from sixteen suppliers. Additional details are available on the IBUPROFEN AND FAMOTIDINE profile page.

The generic ingredient in IBUPROFEN AND FAMOTIDINE is famotidine; ibuprofen. There are eighteen drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.

Summary for 219538

Tradename:	IBUPROFEN AND FAMOTIDINE
Applicant:	Aurobindo Pharma Ltd
Ingredient:	famotidine; ibuprofen
Patents:	0

Pharmacology for NDA: 219538

Mechanism of Action	Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists

Suppliers and Packaging for NDA: 219538

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	219538	ANDA	Aurobindo Pharma Limited	59651-908	59651-908-90	90 TABLET, FILM COATED in 1 BOTTLE (59651-908-90)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	26.6MG;800MG
Approval Date:	Jun 30, 2025	TE:		RLD:	No

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