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Serving 500+ biopharmaceutical companies globally:

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Generated: July 20, 2017

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 Mayne Pharma, Apotex, Apotex Inc, Idt Australia Ltd, Impax Labs, Accord Hlthcare, Mylan, Sun Pharm Inds, Actavis Elizabeth, Kv Pharm, SCS, Watson Labs, and Sun Pharma Global, and is included in twenty-three NDAs. It is available from twenty-eight 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-one suppliers are listed for this compound. Additional details are available on the carbidopa; levodopa profile page.

Summary for NDA: 078536

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:1
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078536

Ingredient-typeAmino Acids, Aromatic
Mechanism of ActionDOPA Decarboxylase Inhibitors

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 Lake Erie Medical DBA Quality Care Products LLC 35356-355 35356-355-30 30 TABLET in 1 BOTTLE (35356-355-30)
CARBIDOPA AND LEVODOPA
carbidopa; levodopa
 TABLET;ORAL 078536 ANDA Lake Erie Medical DBA Quality Care Products LLC 35356-355 35356-355-60 60 TABLET in 1 BOTTLE (35356-355-60)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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Serving 500+ biopharmaceutical companies globally:

Fuji
Cantor Fitzgerald
Merck
Novartis
Queensland Health
Julphar
Chubb
Argus Health
Accenture
Dow

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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