Application 021602
- Type
- NDA
- Sponsor
- MILLENNIUM PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | VELCADE | BORTEZOMIB | INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | 3.5MG/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 63020-049 | VELCADE | bortezomib | Millennium Pharmaceuticals, Inc. | NDA | Current |
| 63020-049 | VELCADE | bortezomib | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 63020-049 | VELCADE | bortezomib | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 63020-049 | VELCADE | bortezomib | Millennium Pharmaceuticals, Inc. | NDA | Current |
| 63020-049 | VELCADE | bortezomib | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 63020-049 | VELCADE | bortezomib | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 63020-049 | VELCADE | bortezomib | Millennium Pharmaceuticals, Inc. | NDA | Current |
| 63020-049 | VELCADE | bortezomib | Takeda Pharmaceuticals America, Inc. | NDA | Current |
| 63020-049 | VELCADE | bortezomib | Takeda Pharmaceuticals America, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69260 | SUPPL | 2021-11-05 |
| 69254 | SUPPL | 2021-11-05 |
| 69127 | SUPPL | 2021-10-26 |
| 69116 | SUPPL | 2021-10-26 |
| 58444 | SUPPL | 2019-04-26 |
| 58430 | SUPPL | 2019-04-26 |
| 50607 | SUPPL | 2017-12-06 |
| 48702 | SUPPL | 2017-06-12 |
| 48694 | SUPPL | 2017-06-12 |
| 37326 | SUPPL | 2015-09-23 |
| 28234 | SUPPL | 2015-09-16 |
| 37325 | SUPPL | 2014-10-09 |
| 28233 | SUPPL | 2014-10-09 |
| 15860 | SUPPL | 2014-08-12 |
| 5831 | SUPPL | 2014-08-12 |
| 51265 | SUPPL | 2012-11-13 |
| 28232 | SUPPL | 2012-10-29 |
| 5830 | SUPPL | 2012-10-29 |
| 37324 | SUPPL | 2012-10-26 |
| 15859 | SUPPL | 2012-10-26 |
| 28230 | SUPPL | 2012-01-25 |
| 37322 | SUPPL | 2012-01-23 |
| 37323 | SUPPL | 2011-11-04 |
| 15858 | SUPPL | 2011-11-04 |
| 28231 | SUPPL | 2011-11-03 |
| 5829 | SUPPL | 2011-11-03 |
| 21755 | SUPPL | 2011-10-10 |
| 51264 | SUPPL | 2011-01-26 |
| 21754 | SUPPL | 2011-01-07 |
| 28229 | SUPPL | 2010-12-07 |
| 15857 | SUPPL | 2010-12-04 |
| 51263 | SUPPL | 2010-04-27 |
| 37321 | SUPPL | 2010-01-12 |
| 37320 | SUPPL | 2010-01-12 |
| 28228 | SUPPL | 2010-01-05 |
| 5828 | SUPPL | 2010-01-05 |
| 5827 | SUPPL | 2009-05-04 |
| 5826 | SUPPL | 2008-06-24 |
| 37319 | SUPPL | 2008-06-23 |
| 5825 | SUPPL | 2007-10-15 |
| 15856 | SUPPL | 2007-10-10 |
| 5824 | SUPPL | 2006-12-28 |
| 15855 | SUPPL | 2006-12-08 |
| 28227 | SUPPL | 2006-06-02 |
| 37318 | SUPPL | 2006-06-01 |
| 28226 | SUPPL | 2005-12-15 |
| 5823 | SUPPL | 2005-03-30 |
| 37317 | SUPPL | 2005-03-25 |
| 5822 | SUPPL | 2004-06-01 |
| 44137 | ORIG | 2003-12-12 |
| 42229 | ORIG | 2003-09-25 |
| 5821 | ORIG | 2003-05-16 |
| 37316 | ORIG | 2003-05-13 |
| 52043 | SUPPL | 1900-01-01 |
| 52042 | SUPPL | 1900-01-01 |
| 52040 | SUPPL | 1900-01-01 |