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Last Updated: December 17, 2025

Details for New Drug Application (NDA): 215067

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NDA 215067 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alembic, Alkem Labs Ltd, Amta, Annora Pharma, Aurobindo Pharma Ltd, Mylan, Novast Labs, Sun Pharm, Zydus Pharms, Encube, G And W Labs Inc, Novitium Pharma, Padagis Israel, Actavis Mid Atlantic, Amneal, Amring Pharms, Quagen, Rising, Sandoz, Actavis Labs Fl, Sinotherapeutics Inc, and Teva Pharms Inc, and is included in thirty-three NDAs. It is available from thirty suppliers. Additional details are available on the MESALAMINE profile page.

The generic ingredient in MESALAMINE is mesalamine. There are twenty-eight drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for 215067

Tradename:	MESALAMINE
Applicant:	Amneal
Ingredient:	mesalamine
Patents:	0

Pharmacology for NDA: 215067

Medical Subject Heading (MeSH) Categories for 215067

Anti-Inflammatory Agents, Non-Steroidal

Suppliers and Packaging for NDA: 215067

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MESALAMINE	mesalamine	TABLET, DELAYED RELEASE;ORAL	215067	ANDA	Amneal Pharmaceuticals LLC	65162-360	65162-360-18	180 TABLET, DELAYED RELEASE in 1 BOTTLE (65162-360-18)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET, DELAYED RELEASE;ORAL			Strength	800MG
Approval Date:	Feb 18, 2025	TE:	AB	RLD:	No

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