Details for New Drug Application (NDA): 207210
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NDA 207210 describes ENTACAPONE, which is a drug marketed by Ajanta Pharma Ltd, Alembic, Aurobindo Pharma Ltd, Macleods Pharms Ltd, Norvium Bioscience, Sun Pharm, Sunshine, and Wockhardt Bio Ag, and is included in eight NDAs. It is available from ten suppliers. Additional details are available on the ENTACAPONE profile page.
The generic ingredient in ENTACAPONE 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.
The generic ingredient in ENTACAPONE 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 207210
| Tradename: | ENTACAPONE |
| Applicant: | Macleods Pharms Ltd |
| Ingredient: | entacapone |
| Patents: | 0 |
Pharmacology for NDA: 207210
| Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Suppliers and Packaging for NDA: 207210
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENTACAPONE | entacapone | TABLET;ORAL | 207210 | ANDA | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8298 | 0615-8298-39 | 30 TABLET in 1 BLISTER PACK (0615-8298-39) |
| ENTACAPONE | entacapone | TABLET;ORAL | 207210 | ANDA | Macleods Pharmaceuticals Limited | 33342-260 | 33342-260-11 | 100 TABLET in 1 BOTTLE (33342-260-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jun 5, 2017 | TE: | AB | RLD: | No | ||||
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