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Generated: October 18, 2017

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 Alkem Labs Ltd, Vintage Pharms Llc, West-ward Pharms Int, Dr Reddys Labs Ltd, Accord Hlthcare, Apotex Corp, Mylan, Zydus Pharms Usa Inc, Sandoz, Strides Pharma, Teva Pharms, Jubilant Cadista, Apotex, Akorn Inc, Mylan Labs Ltd, and Par Sterile Products, and is included in twenty-nine 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 NDA: 065410

Tradename:
1
Applicant:
1
Ingredient:
1
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 0054-0163-25 100 CAPSULE in 1 BOTTLE (0054-0163-25)
MYCOPHENOLATE MOFETIL
mycophenolate mofetil
CAPSULE;ORAL 065410 ANDA West-Ward Pharmaceuticals Corp 0054-0163 0054-0163-29 500 CAPSULE in 1 BOTTLE (0054-0163-29)

Summary for product number 001

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


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