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Details for New Drug Application (NDA): 204291

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NDA 204291 describes CARBIDOPA, which is a drug marketed by Edenbridge Pharms, Amerigen Pharms Ltd, Alvogen Malta, Mayne Pharma, Apotex, Apotex Inc, Idt Australia Ltd, Impax Labs, Accord Hlthcare, Mylan, Sun Pharm Inds, Actavis Elizabeth, Kv Pharm, SCS, Watson Labs, Sun Pharma Global, and Wockhardt Ltd, and is included in twenty-nine NDAs. It is available from four suppliers. Additional details are available on the CARBIDOPA profile page.

The generic ingredient in CARBIDOPA is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.

Summary for NDA: 204291

Tradename:
CARBIDOPA
Applicant:
Alvogen Malta
Ingredient:
carbidopa
Patents:0
Therapeutic Class:Antiparkinson Agents
Formulation / Manufacturing:see details

Suppliers and Packaging for NDA: 204291

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA
carbidopa
TABLET;ORAL 204291 ANDA Alvogen Inc. 47781-332 47781-332-01 100 TABLET in 1 BOTTLE (47781-332-01)
CARBIDOPA
carbidopa
TABLET;ORAL 204291 ANDA Alvogen Inc. 47781-332 47781-332-05 500 TABLET in 1 BOTTLE (47781-332-05)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jan 8, 2016TE:ABRLD:No


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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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