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Serving hundreds of leading biopharmaceutical companies globally:

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Generated: March 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065520

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NDA 065520 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 eighteen 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 065520
Ingredient:mycophenolate mofetil
Formulation / Manufacturing:see details
Pharmacology for NDA: 065520
Suppliers and Packaging for NDA: 065520
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOPHENOLATE MOFETIL mycophenolate mofetil CAPSULE;ORAL 065520 ANDA Mylan Pharmaceuticals Inc. 0378-2250 N 0378-2250-01
MYCOPHENOLATE MOFETIL mycophenolate mofetil CAPSULE;ORAL 065520 ANDA Mylan Pharmaceuticals Inc. 0378-2250 N 0378-2250-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:May 4, 2009TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Queensland Health
Chinese Patent Office
Express Scripts

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