BioPharmaceutical Business Intelligence

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
McKesson
Argus Health
Johnson and Johnson
Novartis
Cipla
Boehringer Ingelheim
Julphar
QuintilesIMS
Deloitte

Generated: January 20, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078536

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NDA 078536 describes CARBIDOPA AND LEVODOPA, which is a drug marketed by Accord Hlthcare, Apotex, Impax Labs, Kv Pharm, Mylan, Sun Pharm Inds, Sun Pharma Global, Actavis Elizabeth, Apotex Inc, Idt Australia Ltd, Mayne Pharma, SCS, and Watson Labs, and is included in twenty-three NDAs. It is available from twenty-nine suppliers. Additional details are available on the CARBIDOPA AND LEVODOPA profile page.

The generic ingredient in CARBIDOPA AND LEVODOPA is carbidopa; levodopa. There are eighteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.
Summary for 078536
Tradename:CARBIDOPA AND LEVODOPA
Applicant:Sun Pharm Inds
Ingredient:carbidopa; levodopa
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 078536
Ingredient-typeAmino Acids, Aromatic
Suppliers and Packaging for NDA: 078536
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 078536 ANDA Unit Dose Services 50436-6753 50436-6753-2 60 TABLET in 1 BOTTLE (50436-6753-2)
CARBIDOPA AND LEVODOPA carbidopa; levodopa TABLET;ORAL 078536 ANDA Unit Dose Services 50436-6753 50436-6753-1 30 TABLET in 1 BOTTLE (50436-6753-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG;100MG
Approval Date:Oct 28, 2008TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;100MG
Approval Date:Oct 28, 2008TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;250MG
Approval Date:Oct 28, 2008TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Queensland Health
Baxter
Healthtrust
Julphar
Argus Health
Medtronic
AstraZeneca
US Army
UBS

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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