Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 210519
Company: ALKEM LABS LTD
Company: ALKEM LABS LTD
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 |
---|---|---|---|---|---|---|---|
11/20/2019 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210519Orig1s000ltr.pdf |
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 | GLENMARK SPECLT |
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 |
DEFERASIROX | DEFERASIROX | 125MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 207124 | TEVA PHARMS USA |
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 | GLENMARK SPECLT |
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 |
DEFERASIROX | DEFERASIROX | 250MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 207124 | TEVA PHARMS USA |
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 | GLENMARK SPECLT |
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 |
DEFERASIROX | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | No | AB | 207124 | TEVA PHARMS USA |
EXJADE | DEFERASIROX | 500MG | TABLET, FOR SUSPENSION;ORAL | Prescription | Yes | AB | 021882 | NOVARTIS |