Application 022025
- Type
- NDA
- Sponsor
- CLINIGEN
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TOTECT | DEXRAZOXANE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 500MG BASE/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66220-110 | Totect | dexrazoxane hydrochloride | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 66220-110 | Totect | dexrazoxane hydrochloride | Cumberland Pharmaceuticals Inc. | NDA | Current |
| 76310-110 | Totect | dexrazoxane hydrochloride | CLINIGEN GROUP PLC | NDA | Current |
| 76310-110 | Totect | dexrazoxane hydrochloride | CLINIGEN GROUP PLC | NDA | Current |
| 76310-110 | Totect | dexrazoxane hydrochloride | CLINIGEN GROUP PLC | NDA | Current |
| 76310-110 | Totect | dexrazoxane hydrochloride | CLINIGEN GROUP PLC | NDA | Current |
| 76310-110 | Totect | dexrazoxane hydrochloride | Clinigen Limited | NDA | Current |
| 76310-110 | Totect | dexrazoxane hydrochloride | CLINIGEN GROUP PLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 65134 | SUPPL | 2020-11-03 |
| 65127 | SUPPL | 2020-11-03 |
| 56526 | SUPPL | 2018-11-20 |
| 56504 | SUPPL | 2018-11-16 |
| 52543 | SUPPL | 2018-02-09 |
| 52523 | SUPPL | 2018-02-09 |
| 49057 | SUPPL | 2017-07-25 |
| 29101 | SUPPL | 2013-04-30 |
| 38103 | SUPPL | 2013-04-29 |
| 29100 | SUPPL | 2011-03-10 |
| 44665 | ORIG | 2009-11-24 |
| 42390 | ORIG | 2009-11-24 |
| 29099 | SUPPL | 2009-11-10 |
| 16792 | SUPPL | 2009-09-21 |
| 6714 | SUPPL | 2009-02-18 |
| 38102 | SUPPL | 2009-02-12 |
| 29098 | ORIG | 2007-09-11 |
| 16791 | ORIG | 2007-09-10 |