Application 021829

Type
NDA
Sponsor
UCB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NEUPROROTIGOTINEFILM, EXTENDED RELEASE;TRANSDERMAL2MG/24HRYesYes
002NEUPROROTIGOTINEFILM, EXTENDED RELEASE;TRANSDERMAL4MG/24HRYesNo
003NEUPROROTIGOTINEFILM, EXTENDED RELEASE;TRANSDERMAL6MG/24HRYesNo
004NEUPROROTIGOTINEFILM, EXTENDED RELEASE;TRANSDERMAL1MG/24HRYesNo
005NEUPROROTIGOTINEFILM, EXTENDED RELEASE;TRANSDERMAL3MG/24HRYesNo
006NEUPROROTIGOTINEFILM, EXTENDED RELEASE;TRANSDERMAL8MG/24HRYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021829-001NEUPROROTIGOTINE2MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2007-05-09
N021829-002NEUPROROTIGOTINE4MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-09
N021829-003NEUPROROTIGOTINE6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-09
N021829-004NEUPROROTIGOTINE1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-02
N021829-005NEUPROROTIGOTINE3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-02
N021829-006NEUPROROTIGOTINE8MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-02

Orange Book patents#

Current patent rows page 1 of 1 · 30 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N021829-00182469792027-09-01U-1272Drug product2012-09-11
N021829-00182469792027-09-01U-1273Drug product2012-09-11
N021829-001101305892030-12-22Drug product2018-11-30
N021829-001103501742030-12-22Drug product2019-07-18
N021829-00199251502032-03-01Drug product2018-04-02
N021829-00282469792027-09-01U-1272Drug product
N021829-00282469792027-09-01U-1273Drug product
N021829-002101305892030-12-22Drug product2018-11-30
N021829-002103501742030-12-22Drug product2019-07-18
N021829-00299251502032-03-01Drug product2018-04-02
N021829-00382469792027-09-01U-1272Drug product
N021829-00382469792027-09-01U-1273Drug product
N021829-003101305892030-12-22Drug product2018-11-30
N021829-003103501742030-12-22Drug product2019-07-18
N021829-00399251502032-03-01Drug product2018-04-02
N021829-00482469792027-09-01U-1272Drug product
N021829-00482469792027-09-01U-1273Drug product
N021829-004101305892030-12-22Drug product2018-11-30
N021829-004103501742030-12-22Drug product2019-07-18
N021829-00499251502032-03-01Drug product2018-04-02
N021829-00582469792027-09-01U-1272Drug product
N021829-00582469792027-09-01U-1273Drug product
N021829-005101305892030-12-22Drug product2018-11-30
N021829-005103501742030-12-22Drug product2019-07-18
N021829-00599251502032-03-01Drug product2018-04-02
N021829-00682469792027-09-01U-1272Drug product
N021829-00682469792027-09-01U-1273Drug product
N021829-006101305892030-12-22Drug product2018-11-30
N021829-006103501742030-12-22Drug product2019-07-18
N021829-00699251502032-03-01Drug product2018-04-02

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 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021829-001NEUPRO2MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2007-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-002NEUPRO4MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-003NEUPRO6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-004NEUPRO1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-005NEUPRO3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-006NEUPRO8MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-001NEUPRO2MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2007-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-002NEUPRO4MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-003NEUPRO6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-004NEUPRO1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-005NEUPRO3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-006NEUPRO8MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021829-001NEUPRO2MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2007-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021829-002NEUPRO4MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021829-003NEUPRO6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021829-004NEUPRO1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021829-005NEUPRO3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021829-006NEUPRO8MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021829-001NEUPRO2MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2007-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021829-002NEUPRO4MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021829-003NEUPRO6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021829-004NEUPRO1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021829-005NEUPRO3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021829-006NEUPRO8MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021829-001NEUPRO2MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2007-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021829-002NEUPRO4MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021829-003NEUPRO6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021829-004NEUPRO1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021829-005NEUPRO3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021829-006NEUPRO8MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021829-001NEUPRO2MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2007-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021829-002NEUPRO4MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021829-003NEUPRO6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021829-004NEUPRO1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021829-005NEUPRO3MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021829-006NEUPRO8MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021829-001NEUPRO2MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS2007-05-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021829-002NEUPRO4MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021829-003NEUPRO6MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2007-05-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021829-004NEUPRO1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD2012-04-022680178bc6a6…

Observed Orange Book patent history#

Patent history page 1 of 43 · 1,716 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N021829-00182469792027-09-01U-1272Drug product2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00182469792027-09-01U-1273Drug product2012-09-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-001101305892030-12-22Drug product2018-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-001103501742030-12-22Drug product2019-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00199251502032-03-01Drug product2018-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00282469792027-09-01U-1272Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00282469792027-09-01U-1273Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-002101305892030-12-22Drug product2018-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-002103501742030-12-22Drug product2019-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00299251502032-03-01Drug product2018-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00382469792027-09-01U-1272Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00382469792027-09-01U-1273Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-003101305892030-12-22Drug product2018-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-003103501742030-12-22Drug product2019-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00399251502032-03-01Drug product2018-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00482469792027-09-01U-1272Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00482469792027-09-01U-1273Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-004101305892030-12-22Drug product2018-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-004103501742030-12-22Drug product2019-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00499251502032-03-01Drug product2018-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00582469792027-09-01U-1273Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00582469792027-09-01U-1272Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-005101305892030-12-22Drug product2018-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-005103501742030-12-22Drug product2019-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00599251502032-03-01Drug product2018-04-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00682469792027-09-01U-1273Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00682469792027-09-01U-1272Drug product011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-006101305892030-12-22Drug product2018-11-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-006103501742030-12-22Drug product2019-07-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021829-00699251502032-03-01Drug product2018-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-00182469802025-11-27Drug product2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-00182469792027-09-01U-1272Drug product2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-00182469792027-09-01U-1273Drug product2012-09-1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-001101305892030-12-22Drug product2018-11-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-001103501742030-12-22Drug product2019-07-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-00199251502032-03-01Drug product2018-04-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-00282469802025-11-27Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-00282469792027-09-01U-1272Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-00282469792027-09-01U-1273Drug product31067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021829-002101305892030-12-22Drug product2018-11-3031067a03dcf5…

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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeuproROTIGOTINEUCB, Inc.939e28c5-f3a9-42c0-9a2d-8d471d82a6e02025-06-24Warnings, Adverse reactionsExact identifier
application applno (NDA): 021829
application number: NDA021829
ndc (product): 50474-808
ndc (product): 50474-802
ndc (product): 50474-801
ndc (product): 50474-805
ndc (product): 50474-803
ndc (product): 50474-804
ndc (product): 50474-806

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 35 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
50474-801NeuprorotigotineUCB, Inc.NDACurrent
50474-801NeuprorotigotineUCB, Inc.NDACurrent
50474-801NeuprorotigotineUCB, Inc.NDACurrent
50474-801NeuprorotigotineUCB, Inc.NDACurrent
50474-801NeuprorotigotineUCB, Inc.NDACurrent
50474-802NeuprorotigotineUCB, Inc.NDACurrent
50474-802NeuprorotigotineUCB, Inc.NDACurrent
50474-802NeuprorotigotineUCB, Inc.NDACurrent
50474-802NeuprorotigotineUCB, Inc.NDACurrent
50474-802NeuprorotigotineUCB, Inc.NDACurrent
50474-803NeuprorotigotineUCB, Inc.NDACurrent
50474-803NeuprorotigotineUCB, Inc.NDACurrent
50474-803NeuprorotigotineUCB, Inc.NDACurrent
50474-803NeuprorotigotineUCB, Inc.NDACurrent
50474-803NeuprorotigotineUCB, Inc.NDACurrent
50474-804NeuprorotigotineUCB, Inc.NDACurrent
50474-804NeuprorotigotineUCB, Inc.NDACurrent
50474-804NeuprorotigotineUCB, Inc.NDACurrent
50474-804NeuprorotigotineUCB, Inc.NDACurrent
50474-804NeuprorotigotineUCB, Inc.NDACurrent
50474-805NeuprorotigotineUCB, Inc.NDACurrent
50474-805NeuprorotigotineUCB, Inc.NDACurrent
50474-805NeuprorotigotineUCB, Inc.NDACurrent
50474-805NeuprorotigotineUCB, Inc.NDACurrent
50474-805NeuprorotigotineUCB, Inc.NDACurrent
50474-806NeuprorotigotineUCB, Inc.NDACurrent
50474-806NeuprorotigotineUCB, Inc.NDACurrent
50474-806NeuprorotigotineUCB, Inc.NDACurrent
50474-806NeuprorotigotineUCB, Inc.NDACurrent
50474-806NeuprorotigotineUCB, Inc.NDACurrent
50474-808NeuprorotigotineUCB, Inc.NDACurrent
50474-808NeuprorotigotineUCB, Inc.NDACurrent
50474-808NeuprorotigotineUCB, Inc.NDACurrent
50474-808NeuprorotigotineUCB, Inc.NDACurrent
50474-808NeuprorotigotineUCB, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68089SUPPL2021-07-14
68088SUPPL2021-07-14
68075SUPPL2021-07-14
68074SUPPL2021-07-14
62825SUPPL2020-05-05
62694SUPPL2020-04-28
62688SUPPL2020-04-27
62447SUPPL2020-04-06
57300SUPPL2019-01-22
57289SUPPL2019-01-22
56818SUPPL2018-12-20
56601SUPPL2018-11-30
16430SUPPL2015-03-02
28670SUPPL2015-02-27
28669SUPPL2012-04-04
6274SUPPL2012-04-04
44992SUPPL2012-04-02
44991SUPPL2012-04-02
37730SUPPL2012-04-02
37729SUPPL2012-04-02
21836ORIG2007-07-02
28668ORIG2007-05-16
23076ORIG2007-05-10
16429ORIG2007-05-10