Application 078893
- Type
- ANDA
- Sponsor
- MYLAN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | TABLET, ORALLY DISINTEGRATING;ORAL | 10MG;100MG | No | No |
| 002 | CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | TABLET, ORALLY DISINTEGRATING;ORAL | 25MG;100MG | No | No |
| 003 | CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | TABLET, ORALLY DISINTEGRATING;ORAL | 25MG;250MG | No | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0378-5051 | Carbidopa and Levodopa | carbidopa and levodopa | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5052 | Carbidopa and Levodopa | carbidopa and levodopa | Mylan Pharmaceuticals Inc. | ANDA | Current |
| 0378-5053 | Carbidopa and Levodopa | carbidopa and levodopa | Mylan Pharmaceuticals Inc. | ANDA | Current |