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Last Updated: July 4, 2020

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Details for New Drug Application (NDA): 207271


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NDA 207271 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Mylan, G And W Labs Inc, Perrigo Israel, Amneal Pharms Llc, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz Inc, Zydus Pharms, Actavis Labs Fl, and Sun Pharm, and is included in sixteen NDAs. It is available from fifteen 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. Twenty-six suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 207271
Tradename:MESALAMINE
Applicant:Mylan
Ingredient:mesalamine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 207271
Medical Subject Heading (MeSH) Categories for 207271
Suppliers and Packaging for NDA: 207271
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESALAMINE mesalamine CAPSULE, EXTENDED RELEASE;ORAL 207271 ANDA Mylan Pharmaceuticals Inc. 0378-1375 0378-1375-78 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1375-78)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength375MG
Approval Date:Nov 20, 2019TE:ABRLD:No

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