Application 022534
- Type
- NDA
- Sponsor
- SUN PHARMA GLOBAL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DOCEFREZ | DOCETAXEL | INJECTABLE;INJECTION | 20MG/VIAL | Yes | No |
| 002 | DOCEFREZ | DOCETAXEL | INJECTABLE;INJECTION | 80MG/VIAL | Yes | No |
| 003 | DOCETAXEL | DOCETAXEL | SOLUTION;INTRAVENOUS | 20MG/ML (20MG/ML) | No | No |
| 004 | DOCETAXEL | DOCETAXEL | SOLUTION;INTRAVENOUS | 80MG/4ML (20MG/ML) | No | No |
| 005 | DOCETAXEL | DOCETAXEL | SOLUTION;INTRAVENOUS | 160MG/8ML (20MG/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47335-323 | Docetaxel | Docetaxel | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-323 | Docetaxel | Docetaxel | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-895 | Docetaxel | Docetaxel | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-895 | Docetaxel | Docetaxel | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-939 | Docetaxel | Docetaxel | Sun Pharmaceutical Industries, Inc. | NDA | Current |
| 47335-939 | Docetaxel | Docetaxel | Sun Pharmaceutical Industries, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 75280 | SUPPL | 2023-08-24 |
| 75267 | SUPPL | 2023-08-23 |
| 72862 | SUPPL | 2022-12-12 |
| 72860 | SUPPL | 2022-12-12 |
| 66099 | SUPPL | 2021-02-05 |
| 66070 | SUPPL | 2021-02-03 |
| 61973 | SUPPL | 2020-02-26 |
| 61962 | SUPPL | 2020-02-26 |
| 57262 | SUPPL | 2019-01-18 |
| 57157 | SUPPL | 2019-01-09 |
| 38823 | SUPPL | 2014-11-04 |
| 29841 | SUPPL | 2014-10-31 |
| 38822 | SUPPL | 2012-07-25 |
| 7512 | SUPPL | 2012-07-20 |
| 24334 | ORIG | 2012-02-10 |
| 22049 | ORIG | 2012-02-10 |
| 17689 | ORIG | 2011-05-24 |
| 29840 | ORIG | 2011-05-05 |
| 7511 | ORIG | 2010-03-22 |