Home Applications 203952 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
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N203952-001 DUOPA CARBIDOPA; LEVODOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 41 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N203952-001 DUOPA 4.63MG/ML;20MG/ML SUSPENSION / ENTERAL RLD, RS 2015-01-09 cb3db0bc1861…
Observed Orange Book exclusivity history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 6 matching rows.
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