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Generated: September 26, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 078893

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NDA 078893 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-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 NDA: 078893

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 078893

Ingredient-typeAmino Acids, Aromatic

Suppliers and Packaging for NDA: 078893

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA AND LEVODOPA
carbidopa; levodopa
TABLET, ORALLY DISINTEGRATING;ORAL 078893 ANDA Mylan Pharmaceuticals Inc. 0378-5051 0378-5051-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5051-01)
CARBIDOPA AND LEVODOPA
carbidopa; levodopa
TABLET, ORALLY DISINTEGRATING;ORAL 078893 ANDA Mylan Pharmaceuticals Inc. 0378-5052 0378-5052-01 100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (0378-5052-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength10MG;100MG
Approval Date:Sep 18, 2008TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG;100MG
Approval Date:Sep 18, 2008TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET, ORALLY DISINTEGRATING;ORALStrength25MG;250MG
Approval Date:Sep 18, 2008TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

Argus Health
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Fish and Richardson
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UBS
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Federal Trade Commission
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US Department of Justice

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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