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Last Updated: November 4, 2024

Details for New Drug Application (NDA): 211278

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NDA 211278 describes IBUPROFEN AND FAMOTIDINE, which is a drug marketed by Alkem Labs Ltd, Ascent Pharms Inc, and Teva Pharms Usa, and is included in three NDAs. It is available from eight 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. Eleven suppliers are listed for this compound. Additional details are available on the famotidine; ibuprofen profile page.

Summary for 211278

Tradename:	IBUPROFEN AND FAMOTIDINE
Applicant:	Teva Pharms Usa
Ingredient:	famotidine; ibuprofen
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	26.6MG;800MG
Approval Date:	Oct 29, 2021	TE:	AB	RLD:	No

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