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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 211858


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NDA 211858 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alembic, Alkem Labs Ltd, Amta, Aurobindo Pharma Ltd, Mylan, Sun Pharm, Zydus Pharms, Encube, G And W Labs Inc, Padagis Israel, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz, Actavis Labs Fl, and Sinotherapeutics Inc, and is included in twenty-seven NDAs. It is available from twenty-five 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-six suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 211858
Tradename:MESALAMINE
Applicant:Sun Pharm
Ingredient:mesalamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 211858
Medical Subject Heading (MeSH) Categories for 211858
Suppliers and Packaging for NDA: 211858
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 211858 ANDA Golden State Medical Supply, Inc. 51407-274 51407-274-12 120 TABLET, DELAYED RELEASE in 1 BOTTLE (51407-274-12)
MESALAMINE mesalamine TABLET, DELAYED RELEASE;ORAL 211858 ANDA Sun Pharmaceutical Industries, Inc. 63304-175 63304-175-13 120 TABLET, DELAYED RELEASE in 1 BOTTLE (63304-175-13)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, DELAYED RELEASE;ORALStrength1.2GM
Approval Date:Jan 25, 2019TE:ABRLD:No

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