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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 076751

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NDA 076751 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alembic, Alkem Labs Ltd, Amta, Annora Pharma, Aurobindo Pharma Ltd, Mylan, Novast Labs, Sun Pharm, Zydus Pharms, Encube, G And W Labs Inc, 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-three 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-eight suppliers are listed for this compound. Additional details are available on the mesalamine profile page.

Summary for 076751

Tradename:	MESALAMINE
Applicant:	Padagis Israel
Ingredient:	mesalamine
Patents:	0

Pharmacology for NDA: 076751

Medical Subject Heading (MeSH) Categories for 076751

Anti-Inflammatory Agents, Non-Steroidal

Suppliers and Packaging for NDA: 076751

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
MESALAMINE	mesalamine	ENEMA;RECTAL	076751	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-098	45802-098-28	28 BOTTLE in 1 CARTON (45802-098-28) / 60 mL in 1 BOTTLE
MESALAMINE	mesalamine	ENEMA;RECTAL	076751	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-098	45802-098-51	7 BOTTLE in 1 CARTON (45802-098-51) / 60 mL in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	ENEMA;RECTAL			Strength	4GM/60ML
Approval Date:	Sep 17, 2004	TE:	AB	RLD:	No

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