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Last Updated: October 24, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 214242


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NDA 214242 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-two suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 214242
Tradename:MESALAMINE
Applicant:Alkem Labs Ltd
Ingredient:mesalamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 214242
Medical Subject Heading (MeSH) Categories for 214242
Suppliers and Packaging for NDA: 214242
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESALAMINE mesalamine CAPSULE, EXTENDED RELEASE;ORAL 214242 ANDA Ascend Laboratories, LLC 67877-717 67877-717-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-05)
MESALAMINE mesalamine CAPSULE, EXTENDED RELEASE;ORAL 214242 ANDA Ascend Laboratories, LLC 67877-717 67877-717-12 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (67877-717-12)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength375MG
Approval Date:Jul 15, 2021TE:ABRLD:No

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