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Generated: December 14, 2017

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 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 065520

Tradename:1
Applicant:1
Ingredient:1
Patents:0
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 0378-2250-05 500 CAPSULE in 1 BOTTLE, PLASTIC (0378-2250-05)
MYCOPHENOLATE MOFETIL mycophenolate mofetil CAPSULE;ORAL 065520 ANDA Mylan Pharmaceuticals Inc. 0378-2250 0378-2250-01 100 CAPSULE in 1 BOTTLE, PLASTIC (0378-2250-01)

Summary for product number 001

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


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Serving leading biopharmaceutical companies globally:

Express Scripts
McKesson
AstraZeneca
Merck
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Mallinckrodt
Baxter
Accenture
Cantor Fitzgerald
Moodys

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