Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 205443
Company: ZYDUS LIFESCIENCES
Company: ZYDUS LIFESCIENCES
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | AB | No | No |
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;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 |
---|---|---|---|---|---|---|---|
01/09/2023 | 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 |
---|---|---|---|---|---|
09/19/2023 | SUPPL-1 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
FEBUXOSTAT
TABLET;ORAL; 40MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | No | AB | 205421 | ALEMBIC |
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | No | AB | 212924 | ALKEM LABS LTD |
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | No | AB | 210741 | AUROBINDO PHARMA LTD |
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | No | AB | 205374 | DR REDDYS |
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | No | AB | 205414 | HIKMA |
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | No | AB | 210292 | INDOCO |
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | No | AB | 207293 | MACLEODS PHARMS LTD |
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | No | AB | 206266 | PRINSTON INC |
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | No | AB | 205467 | SUN PHARM |
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | No | AB | 213069 | SUNSHINE |
FEBUXOSTAT | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | No | AB | 205443 | ZYDUS LIFESCIENCES |
ULORIC | FEBUXOSTAT | 40MG | TABLET;ORAL | Prescription | Yes | AB | 021856 | TAKEDA PHARMS USA |
TABLET;ORAL; 80MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | No | AB | 205421 | ALEMBIC |
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | No | AB | 212924 | ALKEM LABS LTD |
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | No | AB | 210741 | AUROBINDO PHARMA LTD |
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | No | AB | 205374 | DR REDDYS |
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | No | AB | 205414 | HIKMA |
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | No | AB | 210292 | INDOCO |
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | No | AB | 207293 | MACLEODS PHARMS LTD |
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | No | AB | 206266 | PRINSTON INC |
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | No | AB | 205467 | SUN PHARM |
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | No | AB | 213069 | SUNSHINE |
FEBUXOSTAT | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | No | AB | 205443 | ZYDUS LIFESCIENCES |
ULORIC | FEBUXOSTAT | 80MG | TABLET;ORAL | Prescription | Yes | AB | 021856 | TAKEDA PHARMS USA |