Application 205266
- Type
- NDA
- Sponsor
- SUN PHARMA GLOBAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ODOMZO | SONIDEGIB PHOSPHATE | CAPSULE;ORAL | EQ 200MG BASE | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47335-303 | Odomzo | sonidegib | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-303 | Odomzo | sonidegib | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-303 | Odomzo | sonidegib | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-303 | Odomzo | sonidegib | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-303 | Odomzo | sonidegib | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-303 | Odomzo | sonidegib | Sun Pharmaceutical Industries, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75279 | SUPPL | 2023-08-24 |
| 75278 | SUPPL | 2023-08-24 |
| 75268 | SUPPL | 2023-08-23 |
| 59100 | ORIG | 2019-06-17 |
| 58728 | SUPPL | 2019-05-15 |
| 58667 | SUPPL | 2019-05-14 |
| 58666 | SUPPL | 2019-05-14 |
| 49845 | SUPPL | 2017-09-22 |
| 49776 | SUPPL | 2017-09-19 |
| 46655 | SUPPL | 2017-01-03 |
| 19631 | SUPPL | 2016-05-17 |
| 10434 | SUPPL | 2016-05-16 |
| 40458 | SUPPL | 2016-03-30 |
| 22981 | ORIG | 2015-08-28 |
| 40457 | ORIG | 2015-07-24 |
| 32650 | ORIG | 2015-07-24 |