omacetaxine mepesuccinate Injectable Solution
- Brand(s)
- Synribo
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Cephalon, Incorporated (2015-11-20)
- Oldest Current Product
- 2012-11-19
- License(s)
- NDA
- RxNORM
- INJECTABLE SOLUTION\OMACETAXINE MEPESUCCINATE
- FDAOB
- SUBCUTANEOUS\POWDER\OMACETAXINE MEPESUCCINATE
- SPL Active
- SUBCUTANEOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\OMACETAXINE MEPESUCCINATE
- SPL Moiety
- SUBCUTANEOUS\INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION\OMACETAXINE
product(s) by strength(s)
omacetaxine mepesuccinate 3.5 mg/ml injectable solution
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|
| 1 | 634590177 | Synribo | NDA | Cephalon, Incorporated | 2012-11-19 | OMACETAXINE MEPESUCCINATE | SUBCUTANEOUS | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA203585 | 83a504ef-cf92-467d-9ecf-d251194a3484 |
| # | id | title | applicant | approved | patent | exclusivity | approved drug |
|---|
| 1 | NDA203585 | SYNRIBO | IVAX INTERNATIONAL GMBH | 2012-10-26 | pRE45128, TREATMENT OF LEUKEMIA, SUBSTANCE
p6987103, TREATMENT OF PATIENTS WITH TYROSINE KINASE INHIBITOR (TKI) RESISTANT OR INTOLERANT CHRONIC MYELOID/MYELOGENOUS LEUKEMIA (CML) | ORPHAN DRUG EXCLUSIVITY [2019-10-26]
NEW CHEMICAL ENTITY [2017-10-26] | NDA203585_001 |
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|
| 1 | NDA203585_001 | RX | OMACETAXINE MEPESUCCINATE (3.5MG/VIAL) | SUBCUTANEOUS | POWDER | True | 2012-10-26 | SYNRIBO |
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|
| 1 | 83a504ef-cf92-467d-9ecf-d251194a3484 (view SPL) | These highlights do not include all the information needed to use SYNRIBO safely and effectively. See full prescribing information for SYNRIBO. SYNRIBO (omacetaxine mepesuccinate) for injection, for subcutaneous use Initial U.S. Approval: 2012 | prescription | Human Prescription | Cephalon, Incorporated | 2015-11-20 | 4 | 634590177 |