Application 205582
- Type
- NDA
- Sponsor
- SUN PHARMA GLOBAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DECITABINE | DECITABINE | POWDER;INTRAVENOUS | 50MG/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47335-361 | decitabine | decitabine | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-361 | decitabine | decitabine | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-361 | decitabine | decitabine | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-361 | decitabine | decitabine | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-361 | decitabine | decitabine | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-361 | decitabine | decitabine | Sun Pharmaceutical Industries, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 64619 | SUPPL | 2020-09-21 |
| 64591 | SUPPL | 2020-09-17 |
| 63314 | SUPPL | 2020-05-28 |
| 63262 | SUPPL | 2020-05-22 |
| 61778 | SUPPL | 2020-02-05 |
| 61773 | SUPPL | 2020-02-04 |
| 58843 | SUPPL | 2019-05-23 |
| 58839 | SUPPL | 2019-05-23 |
| 44923 | ORIG | 2014-06-27 |
| 22994 | ORIG | 2014-06-27 |
| 19660 | ORIG | 2014-01-28 |
| 10469 | ORIG | 2014-01-24 |