Details for New Drug Application (NDA): 212601
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NDA 212601 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 212601
| Tradename: | ENTACAPONE |
| Applicant: | Alembic |
| Ingredient: | entacapone |
| Patents: | 0 |
Pharmacology for NDA: 212601
| Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Suppliers and Packaging for NDA: 212601
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENTACAPONE | entacapone | TABLET;ORAL | 212601 | ANDA | Alembic Pharmaceuticals Limited | 46708-478 | 46708-478-31 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-478-31) |
| ENTACAPONE | entacapone | TABLET;ORAL | 212601 | ANDA | Alembic Pharmaceuticals Limited | 46708-478 | 46708-478-91 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-478-91) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jan 4, 2022 | TE: | AB | RLD: | No | ||||
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