Caspofungin Injectable Solution
- Brand(s)
- Cancidas
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Merck Sharp & Dohme Corp. (2014-09-12)
- Oldest Current Product
- 2001-01-26
- License(s)
- NDA
- RxNORM
- INJECTABLE SOLUTION\CASPOFUNGIN
- FDAOB
- IV (INFUSION)\INJECTION\CASPOFUNGIN ACETATE\rdfq
- SPL Active
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CASPOFUNGIN ACETATE
- SPL Moiety
- INTRAVENOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\CASPOFUNGIN
product(s) by strength(s)
caspofungin 5 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000063822 | Cancidas | NDA | Merck Sharp & Dohme Corp. | 2001-01-26 | CASPOFUNGIN ACETATE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA021227 | 3bad23a6-09a6-4194-9182-093ed61bc71c |
caspofungin 7 mg/ml injectable solution
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000063823 | Cancidas | NDA | Merck Sharp & Dohme Corp. | 2001-01-26 | CASPOFUNGIN ACETATE | INTRAVENOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA021227 | 3bad23a6-09a6-4194-9182-093ed61bc71c |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA021227 | CANCIDAS | MERCK AND CO INC | 2001-01-26 | p5514650, CANCIDAS IS INDICATED FOR EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE, SUBSTANCE p6136783, CANCIDAS IS INDICATED FOR EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE p5952300, SUBSTANCE | NDA021227_001, NDA021227_002 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|
| 1 | NDA021227_001 | RX | CASPOFUNGIN ACETATE (50MG/VIAL) | INJECTION | True | 2001-01-26 | CANCIDAS |
| 2 | NDA021227_002 | RX | CASPOFUNGIN ACETATE (70MG/VIAL) | INJECTION | True | 2001-01-26 | CANCIDAS |
patent(s)
| # | id | expiration date | application(s) |
|---|---|---|---|
| 1 | p5514650 (view patent) | 2015-01-26 | NDA021227 |
| 2 | p5952300 (view patent) | 2017-03-28 | NDA021227 |
| 3 | p6136783 (view patent) | 2017-03-28 | NDA021227 |
spl(s)
| # | id | title | category | type | labeler | labeler act | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|---|
| 1 | 3bad23a6-09a6-4194-9182-093ed61bc71c (view SPL) | These highlights do not include all the information needed to use CANCIDAS safely and effectively. See full prescribing information for CANCIDAS. CANCIDAS (caspofungin acetate) for injection, for intravenous useInitial U.S. Approval: 2001 | prescription | Human Prescription | Merck Sharp & Dohme Corp. | API MANUFACTURE, MANUFACTURE, PACK | 2014-09-12 | 20 | 000063822, 000063823 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII