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BioPharmaceutical Business Intelligence

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Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Express Scripts
Cantor Fitzgerald
Colorcon
Accenture
Fish and Richardson
Teva
Julphar
Covington
Healthtrust

Generated: September 26, 2017

DrugPatentWatch Database Preview

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, 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 sixteen 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: 065379

Tradename:
1
Applicant:
1
Ingredient:
1
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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Serving 500+ biopharmaceutical companies globally:

Express Scripts
Julphar
Fuji
Johnson and Johnson
Queensland Health
Cerilliant
Teva
Medtronic
Argus Health
Daiichi Sankyo

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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