BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Chubb
Teva
Medtronic
US Army
Boehringer Ingelheim
Federal Trade Commission
Colorcon
Fish and Richardson
Cipla
McKinsey

Generated: January 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 065416

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NDA 065416 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 065416
Tradename:MYCOPHENOLATE MOFETIL
Applicant:Accord Hlthcare
Ingredient:mycophenolate mofetil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 065416
Suppliers and Packaging for NDA: 065416
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 065416 ANDA Accord Healthcare Inc. 16729-019 16729-019-01 100 TABLET in 1 BOTTLE (16729-019-01)
MYCOPHENOLATE MOFETIL mycophenolate mofetil TABLET;ORAL 065416 ANDA Accord Healthcare Inc. 16729-019 16729-019-16 500 TABLET in 1 BOTTLE (16729-019-16)

Profile for product number 001

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

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Serving leading biopharmaceutical companies globally:

Cerilliant
Harvard Business School
Fuji
Accenture
US Department of Justice
Fish and Richardson
Covington
Chinese Patent Office
Argus Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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