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Last Updated: December 12, 2025

Details for New Drug Application (NDA): 213212


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NDA 213212 describes CARBIDOPA, LEVODOPA AND ENTACAPONE, which is a drug marketed by Macleods Pharms Ltd, Pharmobedient, Rising, Sun Pharm, and Wockhardt Ltd, and is included in six NDAs. It is available from two suppliers. Additional details are available on the CARBIDOPA, LEVODOPA AND ENTACAPONE profile page.

The generic ingredient in CARBIDOPA, LEVODOPA AND ENTACAPONE is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.
Summary for 213212
Tradename:CARBIDOPA, LEVODOPA AND ENTACAPONE
Applicant:Rising
Ingredient:carbidopa; entacapone; levodopa
Patents:0
Pharmacology for NDA: 213212
Mechanism of ActionCatechol O-Methyltransferase Inhibitors
Suppliers and Packaging for NDA: 213212
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 213212 ANDA Rising Pharma Holdings, Inc. 16571-689 16571-689-01 100 TABLET, FILM COATED in 1 BOTTLE (16571-689-01)
CARBIDOPA, LEVODOPA AND ENTACAPONE carbidopa; entacapone; levodopa TABLET;ORAL 213212 ANDA Rising Pharma Holdings, Inc. 16571-690 16571-690-01 100 TABLET, FILM COATED in 1 BOTTLE (16571-690-01)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength12.5MG;200MG;50MG
Approval Date:Jan 25, 2022TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength18.75MG;200MG;75MG
Approval Date:Jan 25, 2022TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG;200MG;100MG
Approval Date:Jan 25, 2022TE: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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification 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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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2025, www.DrugPatentWatch.com.
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