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Details for New Drug Application (NDA): 065379

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NDA 065379 describes MYCOPHENOLATE MOFETIL, which is a drug marketed by Alkem Labs Ltd, Vintage Pharms Llc, Roxane, Dr Reddys Labs Ltd, Accord Hlthcare, Apotex Corp, Mylan, Zydus Pharms Usa Inc, Sandoz, Strides Pharma, Teva Pharms, Jubilant Cadista, Apotex, and Par Sterile Products, and is included in twenty-six NDAs. It is available from nineteen suppliers. Additional details are available on the MYCOPHENOLATE MOFETIL profile page.

The generic ingredient in MYCOPHENOLATE MOFETIL is mycophenolate mofetil hydrochloride. There are thirty-five drug master file entries for this compound. Two suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for NDA: 065379

Tradename:
MYCOPHENOLATE MOFETIL
Applicant:
Sandoz
Ingredient:
mycophenolate mofetil
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 065379

Suppliers and Packaging for NDA: 065379

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOPHENOLATE MOFETIL
mycophenolate mofetil
CAPSULE;ORAL 065379 ANDA Sandoz Inc 0781-2067 0781-2067-01 100 CAPSULE in 1 BOTTLE (0781-2067-01)
MYCOPHENOLATE MOFETIL
mycophenolate mofetil
CAPSULE;ORAL 065379 ANDA Sandoz Inc 0781-2067 0781-2067-05 500 CAPSULE in 1 BOTTLE (0781-2067-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength250MG
Approval Date:Oct 15, 2008TE:ABRLD:No


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