Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 204616
Company: QILU PHARM HAINAN
Company: QILU PHARM HAINAN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
OXALIPLATIN | OXALIPLATIN | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | No | No |
OXALIPLATIN | OXALIPLATIN | 100MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | 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 |
---|---|---|---|---|---|---|---|
05/11/2016 | ORIG-1 | Approval |
Label is not available on this site. |
OXALIPLATIN
INJECTABLE;INTRAVENOUS; 50MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXALIPLATIN | OXALIPLATIN | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 078819 | FRESENIUS KABI USA |
OXALIPLATIN | OXALIPLATIN | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207385 | GLAND PHARMA LTD |
OXALIPLATIN | OXALIPLATIN | 50MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204616 | QILU PHARM HAINAN |
INJECTABLE;INTRAVENOUS; 100MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
OXALIPLATIN | OXALIPLATIN | 100MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 078819 | FRESENIUS KABI USA |
OXALIPLATIN | OXALIPLATIN | 100MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 207385 | GLAND PHARMA LTD |
OXALIPLATIN | OXALIPLATIN | 100MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 204616 | QILU PHARM HAINAN |