Last Updated: August 10, 2026

Details for New Drug Application (NDA): 215269

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NDA 215269 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alembic, Alkem Labs Ltd, Amta, Annora Pharma, Aurobindo Pharma Ltd, Difgen Pharms, Mylan, Novast Labs, Sun Pharm, Zydus Pharms, Encube, G And W Labs Inc, Klm Labs Pvt, Novitium Pharma, Padagis Israel, Actavis Mid Atlantic, Amneal, J Molner, Quagen, Rising, Sandoz, Actavis Labs Fl, Sinotherapeutics Inc, and Teva Pharms Inc, and is included in thirty-five NDAs. It is available from thirty-four 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-nine suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for 215269

Tradename:	MESALAMINE
Applicant:	Novitium Pharma
Ingredient:	mesalamine
Patents:	0

Pharmacology for NDA: 215269

Medical Subject Heading (MeSH) Categories for 215269

Anti-Inflammatory Agents, Non-Steroidal

Suppliers and Packaging for NDA: 215269

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MESALAMINE	mesalamine	ENEMA;RECTAL	215269	ANDA	ANI Pharmaceuticals, Inc.	70954-301	70954-301-20	7 BOTTLE in 1 CARTON (70954-301-20) / 60 mL in 1 BOTTLE (70954-301-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	ENEMA;RECTAL			Strength	4GM/60ML
Approval Date:	Apr 16, 2025	TE:	AB	RLD:	No

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