Application 214869
- Type
- NDA
- Sponsor
- RIVERSIDE PHARMA CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DHIVY | CARBIDOPA;LEVODOPA | TABLET;ORAL | 25MG;100MG | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 75854-701 | Dhivy | Carbidopa Levodopa | Avion Pharmaceuticals, LLC | NDA | Current |
| 75854-701 | Dhivy | Carbidopa Levodopa | Avion Pharmaceuticals, LLC | NDA | Current |
| 75854-701 | Dhivy | Carbidopa Levodopa | Avion Pharmaceuticals, LLC | NDA | Current |
| 75854-701 | Dhivy | Carbidopa Levodopa | Avion Pharmaceuticals, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85495 | SUPPL | 2026-03-24 |
| 85451 | SUPPL | 2026-03-23 |
| 71697 | SUPPL | 2022-08-02 |
| 71663 | SUPPL | 2022-07-29 |
| 71507 | SUPPL | 2022-07-05 |
| 71504 | SUPPL | 2022-07-01 |
| 71164 | ORIG | 2022-05-31 |
| 69317 | ORIG | 2021-11-16 |
| 69310 | ORIG | 2021-11-15 |