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Generated: November 20, 2018

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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 nine suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the COMTAN profile page.

The generic ingredient in COMTAN is entacapone. There are nineteen drug master file entries for this compound. Fifteen 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:1
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 KAISER FOUNDATION HOSPITALS 0179-0166 0179-0166-70 30 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (0179-0166-70)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength200MG
Approval Date:Oct 19, 1999TE:ABRLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 14, 2018Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF PARKINSON'S DISEASE

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

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Chinese Patent Office
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Express Scripts
Fuji
US Army
Queensland Health
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