Details for New Drug Application (NDA): 020796
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The generic ingredient in COMTAN is entacapone. There are twenty drug master file entries for this compound. Fourteen 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 |
Pharmacology for NDA: 020796
Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
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 AUTHORIZED GENERIC | Sandoz Inc | 0781-5578 | 0781-5578-01 | 100 TABLET, FILM COATED in 1 BOTTLE (0781-5578-01) |
COMTAN | entacapone | TABLET;ORAL | 020796 | NDA AUTHORIZED GENERIC | Sun Pharmaceutical Industries, Inc. | 47335-007 | 47335-007-88 | 100 TABLET, FILM COATED in 1 BOTTLE (47335-007-88) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
Approval Date: | Oct 19, 1999 | TE: | AB | RLD: | 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 | ⤷ Subscribe | ⤷ Subscribe |
Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | ⤷ Subscribe | ⤷ Subscribe |
Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | ⤷ Subscribe | ⤷ Subscribe |
Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | ⤷ Subscribe | ⤷ Subscribe |
Orion Pharma | COMTAN | entacapone | TABLET;ORAL | 020796-001 | Oct 19, 1999 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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