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AstraZeneca
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Generated: June 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065410

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NDA 065410 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-one 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 065410
Tradename:MYCOPHENOLATE MOFETIL
Applicant:West-ward Pharms Int
Ingredient:mycophenolate mofetil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065410
Suppliers and Packaging for NDA: 065410
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOPHENOLATE MOFETIL mycophenolate mofetil CAPSULE;ORAL 065410 ANDA West-Ward Pharmaceuticals Corp 0054-0163 N 0054-0163-25
MYCOPHENOLATE MOFETIL mycophenolate mofetil CAPSULE;ORAL 065410 ANDA West-Ward Pharmaceuticals Corp 0054-0163 N 0054-0163-29

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Jul 29, 2008TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Cantor Fitzgerald
UBS
Covington
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Mallinckrodt
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