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Serving leading biopharmaceutical companies globally:

Argus Health
US Department of Justice
Daiichi Sankyo
Fish and Richardson

Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 076751

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NDA 076751 describes MESALAMINE, which is a drug marketed by G And W Labs Inc, Perrigo Israel, Mylan Pharms Inc, and Zydus Pharms Usa Inc, and is included in five NDAs. It is available from three 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-one suppliers are listed for this compound. Additional details are available on the mesalamine profile page.
Summary for 076751
Applicant:Perrigo Israel
Therapeutic Class:Inflammatory Bowel Disease Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 076751
Ingredient-typeAminosalicylic Acids
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, UNIT-DOSE in 1 CARTON (45802-098-28) > 60 mL in 1 BOTTLE, UNIT-DOSE
MESALAMINE mesalamine ENEMA;RECTAL 076751 ANDA Perrigo New York Inc 45802-098 45802-098-51 7 BOTTLE, UNIT-DOSE in 1 CARTON (45802-098-51) > 60 mL in 1 BOTTLE, UNIT-DOSE

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Queensland Health
Fish and Richardson
Farmers Insurance

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