Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 214180
Company: TEVA PHARMS USA
Company: TEVA PHARMS USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | AB | No | No |
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | AB | No | No |
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;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 |
---|---|---|---|---|---|---|---|
11/19/2021 | 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 |
---|---|---|---|---|---|
03/20/2024 | SUPPL-5 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
04/07/2023 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
04/07/2023 | SUPPL-1 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
DEFERASIROX
GRANULE;ORAL; 90MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | No | AB | 213374 | ALKEM LABS LTD |
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | No | AB | 216229 | ANNORA PHARMA |
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | No | AB | 214559 | AUCTA |
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | No | AB | 215026 | CIPLA |
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | No | AB | 214650 | MSN |
DEFERASIROX | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | No | AB | 214180 | TEVA PHARMS USA |
JADENU SPRINKLE | DEFERASIROX | 90MG | GRANULE;ORAL | Prescription | Yes | AB | 207968 | NOVARTIS |
GRANULE;ORAL; 180MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | No | AB | 213374 | ALKEM LABS LTD |
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | No | AB | 216229 | ANNORA PHARMA |
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | No | AB | 214559 | AUCTA |
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | No | AB | 215026 | CIPLA |
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | No | AB | 214650 | MSN |
DEFERASIROX | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | No | AB | 214180 | TEVA PHARMS USA |
JADENU SPRINKLE | DEFERASIROX | 180MG | GRANULE;ORAL | Prescription | Yes | AB | 207968 | NOVARTIS |
GRANULE;ORAL; 360MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | No | AB | 213374 | ALKEM LABS LTD |
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | No | AB | 216229 | ANNORA PHARMA |
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | No | AB | 214559 | AUCTA |
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | No | AB | 215026 | CIPLA |
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | No | AB | 214650 | MSN |
DEFERASIROX | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | No | AB | 214180 | TEVA PHARMS USA |
JADENU SPRINKLE | DEFERASIROX | 360MG | GRANULE;ORAL | Prescription | Yes | AB | 207968 | NOVARTIS |