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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 204354

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NDA 204354 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 twenty-nine 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. Forty suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for 204354

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

Medical Subject Heading (MeSH) Categories for 204354

Anti-Inflammatory Agents, Non-Steroidal

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUPPOSITORY;RECTAL			Strength	1GM
Approval Date:	Nov 24, 2015	TE:	AB	RLD:	No

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