Details for New Drug Application (NDA): 213212
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NDA 213212 describes CARBIDOPA, LEVODOPA AND ENTACAPONE, which is a drug marketed by Norvium Bioscience, Rising, Sun Pharm, and Wockhardt Ltd, and is included in five NDAs. It is available from one supplier. Additional details are available on the CARBIDOPA, LEVODOPA AND ENTACAPONE profile page.
The generic ingredient in CARBIDOPA, LEVODOPA AND ENTACAPONE is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.
The generic ingredient in CARBIDOPA, LEVODOPA AND ENTACAPONE is carbidopa; entacapone; levodopa. There are eighteen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.
Summary for 213212
| Tradename: | CARBIDOPA, LEVODOPA AND ENTACAPONE |
| Applicant: | Rising |
| Ingredient: | carbidopa; entacapone; levodopa |
| Patents: | 0 |
Pharmacology for NDA: 213212
| Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Suppliers and Packaging for NDA: 213212
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | carbidopa; entacapone; levodopa | TABLET;ORAL | 213212 | ANDA | Rising Pharma Holdings, Inc. | 16571-689 | 16571-689-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16571-689-01) |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | carbidopa; entacapone; levodopa | TABLET;ORAL | 213212 | ANDA | Rising Pharma Holdings, Inc. | 16571-690 | 16571-690-01 | 100 TABLET, FILM COATED in 1 BOTTLE (16571-690-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;200MG;50MG | ||||
| Approval Date: | Jan 25, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 18.75MG;200MG;75MG | ||||
| Approval Date: | Jan 25, 2022 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;200MG;100MG | ||||
| Approval Date: | Jan 25, 2022 | TE: | AB | RLD: | No | ||||
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