Application 021866
- Type
- NDA
- Sponsor
- OTSUKA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ABILIFY | ARIPIPRAZOLE | INJECTABLE;INTRAMUSCULAR | 9.75MG/1.3ML (7.5MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 59148-016 | ABILIFY | ARIPIPRAZOLE | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-016 | ABILIFY | ARIPIPRAZOLE | Otsuka America Pharmaceutical, Inc. | NDA | Current |
| 59148-016 | ABILIFY | ARIPIPRAZOLE | Otsuka America Pharmaceutical, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 61831 | SUPPL | 2020-02-06 |
| 61830 | SUPPL | 2020-02-06 |
| 61829 | SUPPL | 2020-02-06 |
| 61828 | SUPPL | 2020-02-06 |
| 61801 | SUPPL | 2020-02-06 |
| 61800 | SUPPL | 2020-02-06 |
| 59640 | SUPPL | 2019-08-08 |
| 59639 | SUPPL | 2019-08-08 |
| 59625 | SUPPL | 2019-08-08 |
| 47427 | SUPPL | 2017-03-02 |
| 47327 | SUPPL | 2017-02-24 |
| 45052 | SUPPL | 2016-08-23 |
| 45053 | SUPPL | 2016-08-18 |
| 37792 | SUPPL | 2016-01-22 |
| 6342 | SUPPL | 2016-01-20 |
| 16485 | SUPPL | 2014-12-15 |
| 6341 | SUPPL | 2014-12-15 |
| 6339 | SUPPL | 2014-07-11 |
| 37790 | SUPPL | 2014-06-10 |
| 37791 | SUPPL | 2013-08-09 |
| 6340 | SUPPL | 2013-08-05 |
| 28743 | SUPPL | 2012-02-27 |
| 37789 | SUPPL | 2012-02-24 |
| 42333 | SUPPL | 2012-01-27 |
| 42332 | SUPPL | 2012-01-27 |
| 21847 | SUPPL | 2012-01-27 |
| 44158 | ORIG | 2011-12-22 |
| 28742 | SUPPL | 2011-03-08 |
| 37788 | SUPPL | 2011-03-07 |
| 37786 | SUPPL | 2011-02-24 |
| 6337 | SUPPL | 2011-02-18 |
| 28741 | SUPPL | 2010-12-07 |
| 16484 | SUPPL | 2010-12-03 |
| 6338 | SUPPL | 2010-12-03 |
| 37787 | SUPPL | 2010-12-02 |
| 28740 | SUPPL | 2010-02-17 |
| 28733 | SUPPL | 2010-02-14 |
| 16481 | SUPPL | 2010-02-14 |
| 28739 | SUPPL | 2009-07-24 |
| 37785 | SUPPL | 2009-07-23 |
| 37784 | SUPPL | 2008-08-26 |
| 28738 | SUPPL | 2008-08-19 |
| 24222 | ORIG | 2008-08-12 |
| 21846 | ORIG | 2008-08-11 |
| 44655 | SUPPL | 2008-07-17 |
| 44654 | SUPPL | 2008-07-17 |
| 44653 | SUPPL | 2008-07-17 |
| 28736 | SUPPL | 2008-05-14 |
| 28735 | SUPPL | 2008-05-14 |
| 6335 | SUPPL | 2008-05-14 |
| 28737 | SUPPL | 2008-03-07 |
| 6336 | SUPPL | 2008-02-29 |
| 16483 | SUPPL | 2008-02-28 |
| 37783 | SUPPL | 2007-11-19 |
| 28734 | SUPPL | 2007-11-19 |
| 6334 | SUPPL | 2007-11-08 |
| 16482 | SUPPL | 2007-11-07 |
| 28732 | SUPPL | 2007-10-04 |
| 16480 | SUPPL | 2007-09-26 |
| 6333 | ORIG | 2006-09-25 |
| 37782 | ORIG | 2006-09-21 |
| 51608 | SUPPL | 1900-01-01 |