Application 076521
- Type
- ANDA
- Sponsor
- IMPAX LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | TABLET, EXTENDED RELEASE;ORAL | 25MG;100MG | No | No |
| 002 | CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | TABLET, EXTENDED RELEASE;ORAL | 50MG;200MG | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 60219-2033 | Carbidopa and Levodopa | CARBIDOPA and LEVODOPA | Amneal Pharmaceuticals NY LLC | ANDA | Current |
| 60219-2034 | Carbidopa and Levodopa | CARBIDOPA and LEVODOPA | Amneal Pharmaceuticals NY LLC | ANDA | Current |