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Last Updated: December 28, 2025

Details for New Drug Application (NDA): 203658

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NDA 203658 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 Pharms, and is included in seven NDAs. It is available from fifteen 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. Fifteen suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.

Summary for 203658

Tradename:	IBUPROFEN AND FAMOTIDINE
Applicant:	Ph Health
Ingredient:	famotidine; ibuprofen
Patents:	0

Pharmacology for NDA: 203658

Mechanism of Action	Cyclooxygenase Inhibitors Histamine H2 Receptor Antagonists

Suppliers and Packaging for NDA: 203658

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	203658	ANDA	ENDO USA, Inc.	49884-366	49884-366-09	90 TABLET in 1 BOTTLE (49884-366-09)
IBUPROFEN AND FAMOTIDINE	famotidine; ibuprofen	TABLET;ORAL	203658	ANDA	Advanced Rx of Tennessee, LLC	80425-0483	80425-0483-1	30 TABLET in 1 BOTTLE (80425-0483-1)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	26.6MG;800MG
Approval Date:	Mar 22, 2024	TE:	AB	RLD:	No

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