Application 021227
- Type
- NDA
- Sponsor
- MERCK
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CANCIDAS | CASPOFUNGIN ACETATE | POWDER;INTRAVENOUS | 50MG/VIAL | Yes | Yes |
| 002 | CANCIDAS | CASPOFUNGIN ACETATE | POWDER;INTRAVENOUS | 70MG/VIAL | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0006-3822 | CANCIDAS | CASPOFUNGIN ACETATE | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3822 | CANCIDAS | CASPOFUNGIN ACETATE | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3822 | CANCIDAS | CASPOFUNGIN ACETATE | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3822 | CANCIDAS | CASPOFUNGIN ACETATE | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3822 | CANCIDAS | CASPOFUNGIN ACETATE | Merck Sharp & Dohme LLC | NDA | Current |
| 0006-3823 | CANCIDAS | CASPOFUNGIN ACETATE | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3823 | CANCIDAS | CASPOFUNGIN ACETATE | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3823 | CANCIDAS | CASPOFUNGIN ACETATE | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3823 | CANCIDAS | CASPOFUNGIN ACETATE | Merck Sharp & Dohme Corp. | NDA | Current |
| 0006-3823 | CANCIDAS | CASPOFUNGIN ACETATE | Merck Sharp & Dohme LLC | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 69538 | SUPPL | 2021-12-13 |
| 69111 | SUPPL | 2021-10-26 |
| 57713 | SUPPL | 2019-02-20 |
| 57500 | SUPPL | 2019-02-12 |
| 52988 | SUPPL | 2018-03-15 |
| 52978 | SUPPL | 2018-03-15 |
| 49624 | SUPPL | 2017-08-30 |
| 49560 | SUPPL | 2017-08-25 |
| 49403 | SUPPL | 2017-08-15 |
| 49340 | SUPPL | 2017-08-11 |
| 27136 | SUPPL | 2016-04-14 |
| 4700 | SUPPL | 2016-04-14 |
| 36414 | SUPPL | 2016-04-13 |
| 14679 | SUPPL | 2016-04-13 |
| 36413 | SUPPL | 2014-11-18 |
| 27135 | SUPPL | 2014-10-27 |
| 36412 | SUPPL | 2013-08-06 |
| 4698 | SUPPL | 2013-08-05 |
| 14678 | SUPPL | 2013-01-11 |
| 4699 | SUPPL | 2013-01-10 |
| 27134 | SUPPL | 2012-05-02 |
| 4697 | SUPPL | 2010-11-02 |
| 36411 | SUPPL | 2010-10-25 |
| 4696 | SUPPL | 2010-02-05 |
| 14677 | SUPPL | 2010-02-04 |
| 27132 | SUPPL | 2009-06-30 |
| 14676 | SUPPL | 2009-06-29 |
| 27133 | SUPPL | 2009-05-07 |
| 36410 | SUPPL | 2008-08-13 |
| 21525 | SUPPL | 2008-07-31 |
| 4694 | SUPPL | 2008-07-31 |
| 4695 | SUPPL | 2008-07-24 |
| 51284 | SUPPL | 2007-08-15 |
| 36409 | SUPPL | 2005-02-17 |
| 27131 | SUPPL | 2005-02-17 |
| 36407 | SUPPL | 2004-10-04 |
| 27130 | SUPPL | 2004-10-04 |
| 4691 | SUPPL | 2004-05-28 |
| 36408 | SUPPL | 2004-04-05 |
| 14675 | SUPPL | 2004-04-05 |
| 4693 | SUPPL | 2004-03-24 |
| 4692 | SUPPL | 2004-03-24 |
| 36406 | SUPPL | 2003-03-07 |
| 36405 | SUPPL | 2002-11-21 |
| 27129 | SUPPL | 2002-11-21 |
| 36404 | SUPPL | 2002-09-20 |
| 27128 | SUPPL | 2002-09-20 |
| 14674 | SUPPL | 2002-09-20 |
| 4690 | SUPPL | 2002-09-20 |
| 42039 | ORIG | 2001-01-26 |
| 14673 | ORIG | 2001-01-26 |
| 4689 | ORIG | 2001-01-26 |
| 58103 | ORIG | 1900-01-01 |
| 54102 | ORIG | 1900-01-01 |
| 54101 | ORIG | 1900-01-01 |
| 54100 | ORIG | 1900-01-01 |