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Application 216505
- Type
- ANDA
- Sponsor
- RUBICON
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | TABLET;ORAL | 10MG;100MG | No | No |
| 002 | CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | TABLET;ORAL | 25MG;100MG | No | No |
| 003 | CARBIDOPA AND LEVODOPA | CARBIDOPA; LEVODOPA | TABLET;ORAL | 25MG;250MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 72888-106 | Carbidopa-levodopa | carbidopa and levodopa | Advagen Pharma Ltd., | ANDA | Current |
| 72888-107 | Carbidopa-levodopa | carbidopa and levodopa | Advagen Pharma Ltd., | ANDA | Current |
| 72888-108 | Carbidopa-levodopa | carbidopa and levodopa | Advagen Pharma Ltd., | ANDA | Current |