deferasirox Oral Tablet
- Brand(s)
- Jadenu
- Category(s)
- prescription
- SPL Type(s)
- Human Prescription
- Master SPL
- Novartis Pharmaceuticals Corporation (2015-10-23)
- Oldest Current Product
- 2015-03-30
- License(s)
- NDA
- RxNORM
- ORAL TABLET\DEFERASIROX
- FDAOB
- ORAL\TABLET\DEFERASIROX
- SPL Active
- ORAL\TABLET, FILM COATED\DEFERASIROX
- SPL Moiety
- ORAL\TABLET, FILM COATED\DEFERASIROX
product(s) by strength(s)
deferasirox 180 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000780655 | Jadenu | NDA | Novartis Pharmaceuticals Corporation | 2015-03-30 | DEFERASIROX | ORAL | TABLET, FILM COATED | NDA206910 | fee89140-fff1-4443-9f42-24ac004fcda1 |
deferasirox 360 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000780656 | Jadenu | NDA | Novartis Pharmaceuticals Corporation | 2015-03-30 | DEFERASIROX | ORAL | TABLET, FILM COATED | NDA206910 | fee89140-fff1-4443-9f42-24ac004fcda1 |
deferasirox 90 mg oral tablet
original product(s)(s)
| # | id | brand | category | labeler | first marketed | active ingredient(s) | route | dose form | application | spl |
|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 000780654 | Jadenu | NDA | Novartis Pharmaceuticals Corporation | 2015-03-30 | DEFERASIROX | ORAL | TABLET, FILM COATED | NDA206910 | fee89140-fff1-4443-9f42-24ac004fcda1 |
application(s)
| # | id | title | applicant | approved | patent | approved drug |
|---|---|---|---|---|---|---|
| 1 | NDA206910 | JADENU | NOVARTIS PHARMACEUTICALS CORP | 2015-03-30 | p6465504, SUBSTANCE p6596750, METHOD OF TREATING CHRONIC IRON OVERLOAD | NDA206910_001, NDA206910_002, NDA206910_003 |
application drug(s)
| # | id | category/deprecated | ingredient strength(s) | route | dose form | rld | approved | application |
|---|---|---|---|---|---|---|---|---|
| 1 | NDA206910_001 | RX | DEFERASIROX (90MG) | ORAL | TABLET | False | 2015-03-30 | JADENU |
| 2 | NDA206910_002 | RX | DEFERASIROX (180MG) | ORAL | TABLET | False | 2015-03-30 | JADENU |
| 3 | NDA206910_003 | RX | DEFERASIROX (360MG) | ORAL | TABLET | True | 2015-03-30 | JADENU |
patent(s)
| # | id | expiration date | application(s) | in other drug docs |
|---|---|---|---|---|
| 1 | p6465504 (view patent) | 2019-04-05 | NDA206910, NDA021882 | deferasirox Oral Suspension |
| 2 | p6596750 (view patent) | 2017-06-24 | NDA206910, NDA021882 | deferasirox Oral Suspension |
spl(s)
| # | id | title | category | type | labeler | last update | version | product(s) |
|---|---|---|---|---|---|---|---|---|
| 1 | fee89140-fff1-4443-9f42-24ac004fcda1 (view SPL) | These highlights do not include all the information needed to use JADENU safely and effectively. See full prescribing information for JADENU. JADENU (deferasirox) tablets, for oral use Initial U.S. Approval: 2005 | prescription | Human Prescription | Novartis Pharmaceuticals Corporation | 2015-10-23 | 4 | 000780654, 000780655, 000780656 |
Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII