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Generated: June 23, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 091249

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NDA 091249 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-eight NDAs. It is available from eighteen 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. Three suppliers are listed for this compound. Additional details are available on the mycophenolate mofetil hydrochloride profile page.

Summary for NDA: 091249

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Formulation / Manufacturing:see details

Pharmacology for NDA: 091249

Suppliers and Packaging for NDA: 091249

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
MYCOPHENOLATE MOFETIL
mycophenolate mofetil
TABLET;ORAL 091249 ANDA Ascend Laboratories, LLC 67877-225 67877-225-01 100 TABLET, FILM COATED in 1 BOTTLE (67877-225-01)
MYCOPHENOLATE MOFETIL
mycophenolate mofetil
TABLET;ORAL 091249 ANDA Ascend Laboratories, LLC 67877-225 67877-225-05 500 TABLET, FILM COATED in 1 BOTTLE (67877-225-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength500MG
Approval Date:Nov 4, 2011TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Fuji
US Department of Justice
AstraZeneca
Daiichi Sankyo
QuintilesIMS
Argus Health
Fish and Richardson
Farmers Insurance
Chubb
Deloitte

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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