Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075992
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VINORELBINE TARTRATE | VINORELBINE TARTRATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | 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 |
---|---|---|---|---|---|---|---|
06/10/2003 | ORIG-1 | Approval |
Label is not available on this site. |
VINORELBINE TARTRATE
INJECTABLE;INJECTION; EQ 10MG BASE/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
VINORELBINE TARTRATE | VINORELBINE TARTRATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 078011 | ACTAVIS TOTOWA |
VINORELBINE TARTRATE | VINORELBINE TARTRATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 202017 | DR REDDYS |
VINORELBINE TARTRATE | VINORELBINE TARTRATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 075992 | HIKMA |
VINORELBINE TARTRATE | VINORELBINE TARTRATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 076461 | HIKMA |
VINORELBINE TARTRATE | VINORELBINE TARTRATE | EQ 10MG BASE/ML | INJECTABLE;INJECTION | Prescription | No | AP | 091106 | JIANGSU HANSOH PHARM |