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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 065521


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NDA 065521 describes MYCOPHENOLATE MOFETIL, which is a drug marketed by Accord Hlthcare, Alkem Labs Ltd, Apotex Corp, Aurobindo Pharma Ltd, Concord Biotech Ltd, Dr Reddys Labs Ltd, Hikma, Jubilant Cadista, Mylan, Sandoz, Strides Pharma, Teva Pharms, Zhejiang Hisun Pharm, Zydus Pharms Usa Inc, Amneal, Hetero Labs Ltd V, Lannett Co Inc, Teva Pharms Usa, Vistapharm, Apotex, Bpi Labs, Meitheal, Mylan Labs Ltd, Par Sterile Products, Rising, Steriscience, and Zydus Pharms, and is included in forty-four NDAs. It is available from twenty-nine suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL profile page.

The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are thirty-eight drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.
Summary for 065521
Tradename:MYCOPHENOLATE MOFETIL
Applicant:Mylan
Ingredient:mycophenolate mofetil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065521
Suppliers and Packaging for NDA: 065521
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 065521 ANDA Mylan Pharmaceuticals Inc. 0378-4472 0378-4472-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4472-01)
MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 065521 ANDA Mylan Pharmaceuticals Inc. 0378-4472 0378-4472-05 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4472-05)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:May 4, 2009TE:ABRLD:No

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