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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020796

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NDA 020796 describes COMTAN, which is a drug marketed by Orion Pharma and is included in one NDA. It is available from seven suppliers. Additional details are available on the COMTAN profile page.

The generic ingredient in COMTAN is entacapone. There are twenty drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the entacapone profile page.
Summary for 020796
Tradename:COMTAN
Applicant:Orion Pharma
Ingredient:entacapone
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020796
Suppliers and Packaging for NDA: 020796
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
COMTAN entacapone TABLET;ORAL 020796 NDA Novartis Pharmaceuticals Corporation 0078-0327 0078-0327-05 100 TABLET, FILM COATED in 1 BOTTLE (0078-0327-05)
COMTAN entacapone TABLET;ORAL 020796 NDA AUTHORIZED GENERIC Mylan Pharmaceuticals Inc. 0378-9080 0378-9080-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-9080-01)
Paragraph IV (Patent) Challenges for 020796
Tradename Dosage Ingredient NDA Submissiondate
COMTAN TABLET;ORAL entacapone 020796 2007-04-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Oct 19, 1999TE:ABRLD:Yes

Expired US Patents for NDA 020796

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999   Start Trial   Start Trial
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999   Start Trial   Start Trial
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999   Start Trial   Start Trial
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999   Start Trial   Start Trial
Orion Pharma COMTAN entacapone TABLET;ORAL 020796-001 Oct 19, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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