Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 208913
Company: ACTAVIS LABS FL INC
Company: ACTAVIS LABS FL INC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
GEFITINIB | GEFITINIB | 250MG | 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 |
---|---|---|---|---|---|---|---|
04/26/2023 | ORIG-1 | Approval | STANDARD |
Label is not available on this site. |
GEFITINIB
TABLET;ORAL; 250MG
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
GEFITINIB | GEFITINIB | 250MG | TABLET;ORAL | Prescription | No | AB | 208913 | ACTAVIS LABS FL INC |
GEFITINIB | GEFITINIB | 250MG | TABLET;ORAL | Prescription | No | AB | 209532 | APOTEX |
GEFITINIB | GEFITINIB | 250MG | TABLET;ORAL | Prescription | No | AB | 212827 | NATCO |
GEFITINIB | GEFITINIB | 250MG | TABLET;ORAL | Prescription | No | AB | 211591 | QILU PHARM HAINAN |
IRESSA | GEFITINIB | 250MG | TABLET;ORAL | Prescription | Yes | AB | 206995 | ASTRAZENECA |