Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 078011
Company: ACTAVIS TOTOWA
Company: ACTAVIS TOTOWA
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 |
---|---|---|---|---|---|---|---|
07/22/2009 | ORIG-1 | Approval |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
07/27/2020 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
07/27/2020 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
10/26/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
05/26/2010 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
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 |