Details for New Drug Application (NDA): 218535
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NDA 218535 describes CARBIDOPA, LEVODOPA AND ENTACAPONE, which is a drug marketed by Alembic, Macleods Pharms Ltd, Pharmobedient, Rising, Sun Pharm, and Wockhardt Ltd, and is included in seven NDAs. It is available from four suppliers. 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. Five 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. Five suppliers are listed for this compound. Additional details are available on the carbidopa; entacapone; levodopa profile page.
Summary for 218535
| Tradename: | CARBIDOPA, LEVODOPA AND ENTACAPONE |
| Applicant: | Alembic |
| Ingredient: | carbidopa; entacapone; levodopa |
| Patents: | 0 |
Pharmacology for NDA: 218535
| Mechanism of Action | Catechol O-Methyltransferase Inhibitors |
Suppliers and Packaging for NDA: 218535
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | carbidopa; entacapone; levodopa | TABLET;ORAL | 218535 | ANDA | Alembic Pharmaceuticals Limited | 46708-795 | 46708-795-31 | 100 TABLET, FILM COATED in 1 BOTTLE (46708-795-31) |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | carbidopa; entacapone; levodopa | TABLET;ORAL | 218535 | ANDA | Alembic Pharmaceuticals Limited | 46708-795 | 46708-795-91 | 1000 TABLET, FILM COATED in 1 BOTTLE (46708-795-91) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 12.5MG;200MG;50MG | ||||
| Approval Date: | Feb 5, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 18.75MG;200MG;75MG | ||||
| Approval Date: | Feb 5, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG;200MG;100MG | ||||
| Approval Date: | Feb 5, 2026 | TE: | AB | RLD: | No | ||||
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