Home Applications 021829 Application 021829
Type NDA
Sponsor UCB INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 NEUPRO ROTIGOTINE FILM, EXTENDED RELEASE;TRANSDERMAL 2MG/24HR Yes Yes 002 NEUPRO ROTIGOTINE FILM, EXTENDED RELEASE;TRANSDERMAL 4MG/24HR Yes No 003 NEUPRO ROTIGOTINE FILM, EXTENDED RELEASE;TRANSDERMAL 6MG/24HR Yes No 004 NEUPRO ROTIGOTINE FILM, EXTENDED RELEASE;TRANSDERMAL 1MG/24HR Yes No 005 NEUPRO ROTIGOTINE FILM, EXTENDED RELEASE;TRANSDERMAL 3MG/24HR Yes No 006 NEUPRO ROTIGOTINE FILM, EXTENDED RELEASE;TRANSDERMAL 8MG/24HR Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 6 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021829-001 NEUPRO ROTIGOTINE 2MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 2007-05-09 N021829-002 NEUPRO ROTIGOTINE 4MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2007-05-09 N021829-003 NEUPRO ROTIGOTINE 6MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2007-05-09 N021829-004 NEUPRO ROTIGOTINE 1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 N021829-005 NEUPRO ROTIGOTINE 3MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 N021829-006 NEUPRO ROTIGOTINE 8MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02
Orange Book patents# Current patent rows page 1 of 1 · 30 matching rows.
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 7 of 7 · 264 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 2022-10-28 04:53 UTC 2022-10 N021829-001 NEUPRO 2MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 2007-05-09 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021829-002 NEUPRO 4MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2007-05-09 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021829-003 NEUPRO 6MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2007-05-09 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021829-004 NEUPRO 1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021829-005 NEUPRO 3MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N021829-006 NEUPRO 8MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021829-001 NEUPRO 2MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 2007-05-09 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021829-002 NEUPRO 4MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2007-05-09 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021829-003 NEUPRO 6MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2007-05-09 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021829-004 NEUPRO 1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021829-005 NEUPRO 3MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 e64feba35796…2022-09-29 23:25 UTC 2022-09 N021829-006 NEUPRO 8MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021829-001 NEUPRO 2MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 2007-05-09 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021829-002 NEUPRO 4MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2007-05-09 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021829-003 NEUPRO 6MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2007-05-09 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021829-004 NEUPRO 1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021829-005 NEUPRO 3MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021829-006 NEUPRO 8MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021829-001 NEUPRO 2MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD, RS 2007-05-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021829-002 NEUPRO 4MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2007-05-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021829-003 NEUPRO 6MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2007-05-09 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021829-004 NEUPRO 1MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021829-005 NEUPRO 3MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021829-006 NEUPRO 8MG/24HR FILM, EXTENDED RELEASE / TRANSDERMAL RLD 2012-04-02 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 46 · 1,806 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-10-15 13:18:30 2026-09 N021829-001 8246979 2027-09-01 U-1272 Drug product 2012-09-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-001 8246979 2027-09-01 U-1273 Drug product 2012-09-11 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-001 10130589 2030-12-22 Drug product 2018-11-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-001 10350174 2030-12-22 Drug product 2019-07-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-001 9925150 2032-03-01 Drug product 2018-04-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-002 8246979 2027-09-01 U-1272 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-002 8246979 2027-09-01 U-1273 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-002 10130589 2030-12-22 Drug product 2018-11-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-002 10350174 2030-12-22 Drug product 2019-07-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-002 9925150 2032-03-01 Drug product 2018-04-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-003 8246979 2027-09-01 U-1272 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-003 8246979 2027-09-01 U-1273 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-003 10130589 2030-12-22 Drug product 2018-11-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-003 10350174 2030-12-22 Drug product 2019-07-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-003 9925150 2032-03-01 Drug product 2018-04-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-004 8246979 2027-09-01 U-1272 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-004 8246979 2027-09-01 U-1273 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-004 10130589 2030-12-22 Drug product 2018-11-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-004 10350174 2030-12-22 Drug product 2019-07-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-004 9925150 2032-03-01 Drug product 2018-04-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-005 8246979 2027-09-01 U-1273 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-005 8246979 2027-09-01 U-1272 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-005 10130589 2030-12-22 Drug product 2018-11-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-005 10350174 2030-12-22 Drug product 2019-07-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-005 9925150 2032-03-01 Drug product 2018-04-02 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-006 8246979 2027-09-01 U-1273 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-006 8246979 2027-09-01 U-1272 Drug product c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-006 10130589 2030-12-22 Drug product 2018-11-30 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-006 10350174 2030-12-22 Drug product 2019-07-18 c2088c7a36db…2026-10-15 13:18:30 2026-09 N021829-006 9925150 2032-03-01 Drug product 2018-04-02 c2088c7a36db…2026-09-14 22:38:34 2026-08 N021829-001 8246979 2027-09-01 U-1272 Drug product 2012-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021829-001 8246979 2027-09-01 U-1273 Drug product 2012-09-11 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021829-001 10130589 2030-12-22 Drug product 2018-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021829-001 10350174 2030-12-22 Drug product 2019-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021829-001 9925150 2032-03-01 Drug product 2018-04-02 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021829-002 8246979 2027-09-01 U-1272 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021829-002 8246979 2027-09-01 U-1273 Drug product 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021829-002 10130589 2030-12-22 Drug product 2018-11-30 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021829-002 10350174 2030-12-22 Drug product 2019-07-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021829-002 9925150 2032-03-01 Drug product 2018-04-02 84e616aacf4f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 35 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50474-801 Neupro rotigotine UCB, Inc. NDA Current 50474-801 Neupro rotigotine UCB, Inc. NDA Current 50474-801 Neupro rotigotine UCB, Inc. NDA Current 50474-801 Neupro rotigotine UCB, Inc. NDA Current 50474-801 Neupro rotigotine UCB, Inc. NDA Current 50474-802 Neupro rotigotine UCB, Inc. NDA Current 50474-802 Neupro rotigotine UCB, Inc. NDA Current 50474-802 Neupro rotigotine UCB, Inc. NDA Current 50474-802 Neupro rotigotine UCB, Inc. NDA Current 50474-802 Neupro rotigotine UCB, Inc. NDA Current 50474-803 Neupro rotigotine UCB, Inc. NDA Current 50474-803 Neupro rotigotine UCB, Inc. NDA Current 50474-803 Neupro rotigotine UCB, Inc. NDA Current 50474-803 Neupro rotigotine UCB, Inc. NDA Current 50474-803 Neupro rotigotine UCB, Inc. NDA Current 50474-804 Neupro rotigotine UCB, Inc. NDA Current 50474-804 Neupro rotigotine UCB, Inc. NDA Current 50474-804 Neupro rotigotine UCB, Inc. NDA Current 50474-804 Neupro rotigotine UCB, Inc. NDA Current 50474-804 Neupro rotigotine UCB, Inc. NDA Current 50474-805 Neupro rotigotine UCB, Inc. NDA Current 50474-805 Neupro rotigotine UCB, Inc. NDA Current 50474-805 Neupro rotigotine UCB, Inc. NDA Current 50474-805 Neupro rotigotine UCB, Inc. NDA Current 50474-805 Neupro rotigotine UCB, Inc. NDA Current 50474-806 Neupro rotigotine UCB, Inc. NDA Current 50474-806 Neupro rotigotine UCB, Inc. NDA Current 50474-806 Neupro rotigotine UCB, Inc. NDA Current 50474-806 Neupro rotigotine UCB, Inc. NDA Current 50474-806 Neupro rotigotine UCB, Inc. NDA Current 50474-808 Neupro rotigotine UCB, Inc. NDA Current 50474-808 Neupro rotigotine UCB, Inc. NDA Current 50474-808 Neupro rotigotine UCB, Inc. NDA Current 50474-808 Neupro rotigotine UCB, Inc. NDA Current 50474-808 Neupro rotigotine UCB, Inc. NDA Current