Application 207695
- Type
- NDA
- Sponsor
- ANACOR PHARMS INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EUCRISA | CRISABOROLE | OINTMENT;TOPICAL | 2% | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 55724-211 | Eucrisa | crisaborole | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 55724-211 | Eucrisa | crisaborole | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 55724-211 | Eucrisa | crisaborole | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
| 55724-211 | Eucrisa | crisaborole | Pfizer Laboratories Div Pfizer Inc | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73961 | SUPPL | 2023-04-07 |
| 73946 | SUPPL | 2023-04-04 |
| 62306 | SUPPL | 2020-03-24 |
| 62305 | SUPPL | 2020-03-24 |
| 62304 | SUPPL | 2020-03-24 |
| 62288 | SUPPL | 2020-03-24 |
| 62287 | SUPPL | 2020-03-24 |
| 62286 | SUPPL | 2020-03-24 |
| 50148 | SUPPL | 2017-10-23 |
| 50089 | SUPPL | 2017-10-18 |
| 46929 | ORIG | 2017-01-23 |
| 46421 | ORIG | 2016-12-21 |
| 46165 | ORIG | 2016-12-15 |
| 63898 | ORIG | 1900-01-01 |
| 63897 | ORIG | 1900-01-01 |
| 52581 | ORIG | 1900-01-01 |
| 52580 | ORIG | 1900-01-01 |
| 52579 | ORIG | 1900-01-01 |
| 52578 | ORIG | 1900-01-01 |