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Serving leading biopharmaceutical companies globally:

US Department of Justice
Merck
Covington
Novartis
US Army
Teva
Argus Health
Healthtrust
AstraZeneca
Colorcon

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065413

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NDA 065413 describes MYCOPHENOLATE MOFETIL, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Corp, Dr Reddys Labs Ltd, Jubilant Cadista, Mylan, Sandoz, Strides Pharma, Teva Pharms, Vintage Pharms Llc, West-ward Pharms Int, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Apotex, Akorn Inc, Mylan Labs Ltd, and Par Sterile Products, and is included in thirty NDAs. It is available from seventeen suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL profile page.

The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are thirty-six drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.
Summary for 065413
Tradename:MYCOPHENOLATE MOFETIL
Applicant:West-ward Pharms Int
Ingredient:mycophenolate mofetil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065413
Suppliers and Packaging for NDA: 065413
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 065413 ANDA West-Ward Pharmaceuticals Corp 0054-0166 0054-0166-25 100 TABLET in 1 BOTTLE (0054-0166-25)
MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 065413 ANDA West-Ward Pharmaceuticals Corp 0054-0166 0054-0166-29 500 TABLET in 1 BOTTLE (0054-0166-29)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Jul 29, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Baxter
McKesson
Express Scripts
Chinese Patent Office
Farmers Insurance
Fuji
Accenture
Queensland Health
Medtronic

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