Application 202570
- Type
- NDA
- Sponsor
- PF PRISM CV
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | XALKORI | CRIZOTINIB | CAPSULE;ORAL | 200MG | Yes | No |
| 002 | XALKORI | CRIZOTINIB | CAPSULE;ORAL | 250MG | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0069-8140 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8140 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8140 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8140 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8140 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8140 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8140 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8140 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8140 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8140 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8141 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8141 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8141 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8141 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8141 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8141 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8141 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8141 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8141 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 0069-8141 | Xalkori | CRIZOTINIB | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75464 | SUPPL | 2023-09-15 |
| 75374 | SUPPL | 2023-09-08 |
| 75370 | SUPPL | 2023-09-07 |
| 71558 | SUPPL | 2022-07-15 |
| 71546 | SUPPL | 2022-07-14 |
| 71545 | SUPPL | 2022-07-14 |
| 68819 | SUPPL | 2021-09-30 |
| 68818 | SUPPL | 2021-09-30 |
| 65931 | SUPPL | 2021-01-19 |
| 65910 | SUPPL | 2021-01-14 |
| 65909 | SUPPL | 2021-01-14 |
| 59183 | SUPPL | 2019-06-27 |
| 59171 | SUPPL | 2019-06-26 |
| 10073 | ORIG | 2018-12-20 |
| 56663 | SUPPL | 2018-12-07 |
| 56661 | SUPPL | 2018-12-07 |
| 56647 | SUPPL | 2018-12-07 |
| 56615 | SUPPL | 2018-12-03 |
| 52521 | SUPPL | 2018-02-08 |
| 52520 | SUPPL | 2018-02-08 |
| 52504 | SUPPL | 2018-02-08 |
| 49068 | SUPPL | 2017-07-25 |
| 49045 | SUPPL | 2017-07-25 |
| 48203 | SUPPL | 2017-05-02 |
| 48175 | SUPPL | 2017-05-01 |
| 47001 | SUPPL | 2017-01-27 |
| 46980 | SUPPL | 2017-01-24 |
| 45692 | SUPPL | 2016-10-28 |
| 10079 | SUPPL | 2016-05-04 |
| 40203 | SUPPL | 2016-05-03 |
| 10080 | SUPPL | 2016-05-02 |
| 40204 | SUPPL | 2016-04-29 |
| 19361 | SUPPL | 2016-03-11 |
| 40202 | SUPPL | 2015-09-23 |
| 32279 | SUPPL | 2015-09-16 |
| 19360 | SUPPL | 2015-03-24 |
| 10078 | SUPPL | 2015-03-24 |
| 32278 | SUPPL | 2014-06-02 |
| 40201 | SUPPL | 2014-05-30 |
| 32277 | SUPPL | 2013-11-25 |
| 40198 | SUPPL | 2013-11-22 |
| 40199 | SUPPL | 2013-10-08 |
| 10077 | SUPPL | 2013-10-08 |
| 10076 | SUPPL | 2013-10-08 |
| 40200 | SUPPL | 2013-10-07 |
| 40197 | SUPPL | 2013-03-15 |
| 10075 | SUPPL | 2013-03-01 |
| 40195 | SUPPL | 2012-03-15 |
| 32276 | SUPPL | 2012-02-29 |
| 10074 | SUPPL | 2012-02-29 |
| 40196 | SUPPL | 2012-02-28 |
| 44862 | ORIG | 2011-09-27 |
| 22892 | ORIG | 2011-09-27 |
| 19359 | ORIG | 2011-08-26 |