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Last Updated: April 12, 2025

Details for New Drug Application (NDA): 210509

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NDA 210509 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alembic, Alkem Labs Ltd, Amta, Aurobindo Pharma Ltd, Mylan, Novast Labs, Sun Pharm, Zydus Pharms, Encube, G And W Labs Inc, Padagis Israel, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Rising, Sandoz, Actavis Labs Fl, Sinotherapeutics Inc, and Teva Pharms Inc, and is included in thirty 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-nine suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for 210509

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

Medical Subject Heading (MeSH) Categories for 210509

Anti-Inflammatory Agents, Non-Steroidal

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	SUPPOSITORY;RECTAL			Strength	1GM
Approval Date:	Jan 2, 2020	TE:		RLD:	No

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