Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 209433
Company: ICHNOS
Company: ICHNOS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | AB | No | No |
DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | AB | No | No |
DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
01/03/2020 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
05/19/2023 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
05/19/2023 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
DEFERASIROX
TABLET, FOR SUSPENSION;ORAL; 125MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 203560 | ACTAVIS ELIZABETH |
DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210060 | ALEMBIC |
DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210519 | ALKEM LABS LTD |
DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210920 | BIONPHARMA |
DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209433 | ICHNOS |
DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209878 | MSN |
DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209782 | SUN PHARM |
EXJADE | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 021882 | NOVARTIS |
TABLET, FOR SUSPENSION;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 203560 | ACTAVIS ELIZABETH |
DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210060 | ALEMBIC |
DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210519 | ALKEM LABS LTD |
DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210920 | BIONPHARMA |
DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209433 | ICHNOS |
DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209878 | MSN |
DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209782 | SUN PHARM |
EXJADE | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 021882 | NOVARTIS |
TABLET, FOR SUSPENSION;ORAL; 500MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 203560 | ACTAVIS ELIZABETH |
DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210060 | ALEMBIC |
DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210519 | ALKEM LABS LTD |
DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 210920 | BIONPHARMA |
DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209433 | ICHNOS |
DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209878 | MSN |
DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 209782 | SUN PHARM |
EXJADE | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 021882 | NOVARTIS |