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Last Updated: September 25, 2021

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Details for New Drug Application (NDA): 076751

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NDA 076751 describes MESALAMINE, which is a drug marketed by Teva Pharms Usa, Alkem Labs Ltd, Mylan, G And W Labs Inc, Perrigo Israel, Actavis Mid Atlantic, Amneal, Amring Pharms, Annora Pharma, Pharm Sourcing, Sandoz Inc, Zydus Pharms, Actavis Labs Fl, and Sun Pharm, and is included in eighteen NDAs. It is available from twenty 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-nine suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 076751
Applicant:Perrigo Israel
Formulation / Manufacturing:see details
Pharmacology for NDA: 076751
Medical Subject Heading (MeSH) Categories for 076751
Suppliers and Packaging for NDA: 076751
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MESALAMINE mesalamine ENEMA;RECTAL 076751 ANDA Perrigo New York Inc 45802-098 45802-098-28 28 BOTTLE in 1 CARTON (45802-098-28) > 60 mL in 1 BOTTLE
MESALAMINE mesalamine ENEMA;RECTAL 076751 ANDA Perrigo New York Inc 45802-098 45802-098-46 60 mL in 1 BOTTLE (45802-098-46)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:ENEMA;RECTALStrength4GM/60ML
Approval Date:Sep 17, 2004TE:ABRLD:No

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