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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 203286


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NDA 203286 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 203286
Tradename:MESALAMINE
Applicant:Zydus Pharms
Ingredient:mesalamine
Patents:0
Pharmacology for NDA: 203286
Medical Subject Heading (MeSH) Categories for 203286
Anti-Inflammatory Agents, Non-Steroidal
Suppliers and Packaging for NDA: 203286
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 203286 ANDA American Health Packaging 60687-408 60687-408-25 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-408-25) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-408-95)
MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 203286 ANDA Zydus Pharmaceuticals USA Inc. 68382-435 68382-435-28 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength800MG
Approval Date:Jul 21, 2017TE:ABRLD:No

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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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