FdaApplication
ANDA 218535
Identifiers
- fda_app_no: ANDA218535
Properties
| Property | Value |
|---|---|
| applicant_name | ALEMBIC PHARMACEUTICALS LTD |
| application_type | ANDA |
| approval_date | 2026-02-05 |
Products (6)
| Product | Active ingredient | Strength | Dosage form |
|---|---|---|---|
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 25MG;200MG;100MG | TABLET;ORAL |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 31.25MG;200MG;125MG | TABLET;ORAL |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 18.75MG;200MG;75MG | TABLET;ORAL |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 37.5MG;200MG;150MG | TABLET;ORAL |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 12.5MG;200MG;50MG | TABLET;ORAL |
| CARBIDOPA, LEVODOPA AND ENTACAPONE | CARBIDOPA; ENTACAPONE; LEVODOPA | 50MG;200MG;200MG | TABLET;ORAL |
6 products