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Application 203952
- Type
- NDA
- Sponsor
- ABBVIE INC
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | DUOPA | CARBIDOPA; LEVODOPA | SUSPENSION;ENTERAL | 4.63MG/ML;20MG/ML | Yes | Yes |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 0074-3012 | Duopa | Carbidopa and Levodopa | AbbVie Inc. | NDA | Current |
| 0074-3012 | Duopa | Carbidopa and Levodopa | AbbVie Inc. | NDA | Current |
| 0074-3012 | Duopa | Carbidopa and Levodopa | AbbVie Inc. | NDA | Current |
| 0074-3012 | Duopa | Carbidopa and Levodopa | AbbVie Inc. | NDA | Current |
| 0074-3012 | Duopa | Carbidopa and Levodopa | AbbVie Inc. | NDA | Current |
| 0074-3012 | Duopa | Carbidopa and Levodopa | AbbVie Inc. | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 85534 | SUPPL | 2026-03-31 |
| 85449 | SUPPL | 2026-03-23 |
| 63315 | SUPPL | 2020-05-28 |
| 63261 | SUPPL | 2020-05-22 |
| 61187 | SUPPL | 2019-12-06 |
| 61174 | SUPPL | 2019-12-06 |
| 45283 | SUPPL | 2016-09-19 |
| 45301 | SUPPL | 2016-09-15 |
| 22938 | ORIG | 2016-07-19 |
| 10259 | ORIG | 2015-01-15 |
| 40331 | ORIG | 2015-01-14 |