Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065078
Company: IVAX SUB TEVA PHARMS
Company: IVAX SUB TEVA PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYCLOSPORINE | CYCLOSPORINE | 100MG/ML | SOLUTION;ORAL | Prescription | AB1 | 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 |
---|---|---|---|---|---|---|---|
03/25/2005 | 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 |
---|---|---|---|---|---|
09/24/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
09/24/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
12/11/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
08/26/2010 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
10/12/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |
CYCLOSPORINE
SOLUTION;ORAL; 100MG/ML
TE Code = AB1
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYCLOSPORINE | CYCLOSPORINE | 100MG/ML | SOLUTION;ORAL | Prescription | No | AB1 | 065025 | ABBVIE |
CYCLOSPORINE | CYCLOSPORINE | 100MG/ML | SOLUTION;ORAL | Prescription | No | AB1 | 065078 | IVAX SUB TEVA PHARMS |
NEORAL | CYCLOSPORINE | 100MG/ML | SOLUTION;ORAL | Prescription | Yes | AB1 | 050716 | NOVARTIS |