Last Updated: May 2, 2026

Details for New Drug Application (NDA): 220016

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NDA 220016 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, Amring Pharms, Quagen, Rising, Sandoz, Actavis Labs Fl, Sinotherapeutics Inc, and Teva Pharms Inc, and is included in thirty-five NDAs. It is available from thirty-one 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-seven suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for 220016

Tradename:	MESALAMINE
Applicant:	Klm Labs Pvt
Ingredient:	mesalamine
Patents:	0

Medical Subject Heading (MeSH) Categories for 220016

Anti-Inflammatory Agents, Non-Steroidal

Suppliers and Packaging for NDA: 220016

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MESALAMINE	mesalamine	ENEMA;RECTAL	220016	ANDA	KLM Laboratories Private Limited	84725-002	84725-002-03	7 BOTTLE in 1 CARTON (84725-002-03) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	ENEMA;RECTAL			Strength	4GM/60ML
Approval Date:	Mar 31, 2026	TE:	AB	RLD:	No

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