Application 021481
- Type
- NDA
- Sponsor
- ROCHE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FUZEON | ENFUVIRTIDE | INJECTABLE;SUBCUTANEOUS | 90MG/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0004-0381 | FUZEON | Enfuvirtide | Genentech, Inc. | NDA | Current |
| 0004-0381 | FUZEON | Enfuvirtide | Genentech, Inc. | NDA | Current |
| 0004-0381 | FUZEON | Enfuvirtide | Genentech, Inc. | NDA | Current |
| 0004-0381 | FUZEON | Enfuvirtide | Genentech, Inc. | NDA | Current |
| 0004-0381 | FUZEON | Enfuvirtide | Genentech, Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 59740 | SUPPL | 2019-08-16 |
| 59731 | SUPPL | 2019-08-16 |
| 57106 | SUPPL | 2019-01-02 |
| 57062 | SUPPL | 2018-12-30 |
| 15569 | SUPPL | 2015-12-08 |
| 5506 | SUPPL | 2015-12-03 |
| 5505 | SUPPL | 2013-11-06 |
| 37044 | SUPPL | 2013-11-01 |
| 15568 | SUPPL | 2012-08-22 |
| 27901 | SUPPL | 2012-08-15 |
| 5504 | SUPPL | 2011-05-03 |
| 37043 | SUPPL | 2011-04-29 |
| 37042 | SUPPL | 2010-01-04 |
| 5503 | SUPPL | 2009-12-31 |
| 5502 | SUPPL | 2008-12-24 |
| 5501 | SUPPL | 2007-01-25 |
| 37040 | SUPPL | 2007-01-24 |
| 37041 | SUPPL | 2006-12-28 |
| 27900 | SUPPL | 2006-12-28 |
| 37039 | SUPPL | 2006-10-02 |
| 27899 | SUPPL | 2006-10-02 |
| 5500 | SUPPL | 2005-08-16 |
| 37038 | SUPPL | 2005-08-15 |
| 5499 | SUPPL | 2005-07-08 |
| 15567 | SUPPL | 2005-07-07 |
| 37037 | SUPPL | 2004-10-18 |
| 27898 | SUPPL | 2004-10-18 |
| 42189 | ORIG | 2003-07-23 |
| 5498 | ORIG | 2003-03-20 |
| 37036 | ORIG | 2003-03-18 |