Last Updated: August 10, 2026

Details for New Drug Application (NDA): 205654

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NDA 205654 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 205654

Tradename:	MESALAMINE
Applicant:	Actavis Mid Atlantic
Ingredient:	mesalamine
Patents:	0

Pharmacology for NDA: 205654

Medical Subject Heading (MeSH) Categories for 205654

Anti-Inflammatory Agents, Non-Steroidal

Suppliers and Packaging for NDA: 205654

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MESALAMINE	mesalamine	SUPPOSITORY;RECTAL	205654	ANDA	Actavis Pharma, Inc.	0472-1915	0472-1915-30	30 POUCH in 1 BOX (0472-1915-30) / 1 SUPPOSITORY in 1 POUCH (0472-1915-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SUPPOSITORY;RECTAL			Strength	1GM
Approval Date:	Aug 14, 2020	TE:	AB	RLD:	No

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