Application 021829
- Type
- NDA
- Sponsor
- UCB INC
Application Products#
| 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 |
NDC Listings For This Application#
| 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 |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 68089 | SUPPL | 2021-07-14 |
| 68088 | SUPPL | 2021-07-14 |
| 68075 | SUPPL | 2021-07-14 |
| 68074 | SUPPL | 2021-07-14 |
| 62825 | SUPPL | 2020-05-05 |
| 62694 | SUPPL | 2020-04-28 |
| 62688 | SUPPL | 2020-04-27 |
| 62447 | SUPPL | 2020-04-06 |
| 57300 | SUPPL | 2019-01-22 |
| 57289 | SUPPL | 2019-01-22 |
| 56818 | SUPPL | 2018-12-20 |
| 56601 | SUPPL | 2018-11-30 |
| 16430 | SUPPL | 2015-03-02 |
| 28670 | SUPPL | 2015-02-27 |
| 28669 | SUPPL | 2012-04-04 |
| 6274 | SUPPL | 2012-04-04 |
| 44992 | SUPPL | 2012-04-02 |
| 44991 | SUPPL | 2012-04-02 |
| 37730 | SUPPL | 2012-04-02 |
| 37729 | SUPPL | 2012-04-02 |
| 21836 | ORIG | 2007-07-02 |
| 28668 | ORIG | 2007-05-16 |
| 23076 | ORIG | 2007-05-10 |
| 16429 | ORIG | 2007-05-10 |