Details for New Drug Application (NDA): 203437
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NDA 203437 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 203437
| Tradename: | ENTACAPONE |
| Applicant: | Aurobindo Pharma Ltd |
| Ingredient: | entacapone |
| Patents: | 0 |
Pharmacology for NDA: 203437
| Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Suppliers and Packaging for NDA: 203437
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ENTACAPONE | entacapone | TABLET;ORAL | 203437 | ANDA | Major Pharmaceuticals | 0904-6822 | 0904-6822-07 | 30 BLISTER PACK in 1 CARTON (0904-6822-07) / 1 TABLET, FILM COATED in 1 BLISTER PACK |
| ENTACAPONE | entacapone | TABLET;ORAL | 203437 | ANDA | AvPAK | 50268-295 | 50268-295-15 | 50 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-295-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-295-11) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 200MG | ||||
| Approval Date: | Jun 19, 2015 | TE: | AB | RLD: | No | ||||
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