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Last Updated: October 20, 2021

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Details for New Drug Application (NDA): 210509

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NDA 210509 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alkem Labs Ltd, Mylan, Zydus Pharms, G And W Labs Inc, Padagis Israel, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz Inc, Actavis Labs Fl, and Sun Pharm, and is included in nineteen NDAs. It is available from twenty-two 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-one suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 210509
Formulation / Manufacturing:see details
Pharmacology for NDA: 210509
Medical Subject Heading (MeSH) Categories for 210509
Suppliers and Packaging for NDA: 210509
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESALAMINE mesalamine SUPPOSITORY;RECTAL 210509 ANDA Amneal Pharmaceuticals NY LLC 69238-1274 69238-1274-3 30 SUPPOSITORY in 1 CARTON (69238-1274-3)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SUPPOSITORY;RECTALStrength1GM
Approval Date:Jan 2, 2020TE:ABRLD:No

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Boehringer Ingelheim

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