Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 065004
Company: HIKMA
Company: HIKMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CYCLOSPORINE | CYCLOSPORINE | 50MG/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 |
---|---|---|---|---|---|---|---|
10/29/1999 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/65004LTR.PDF |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
10/18/2010 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
09/23/2010 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
04/03/2001 | SUPPL-2 | Manufacturing (CMC)-Microbiology-Processing |
Label is not available on this site. |
||
04/30/2002 | SUPPL-1 | Labeling |
Label is not available on this site. |
CYCLOSPORINE
INJECTABLE;INJECTION; 50MG/ML
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CYCLOSPORINE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065004 | HIKMA |
CYCLOSPORINE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | No | AP | 065151 | PADAGIS US |
SANDIMMUNE | CYCLOSPORINE | 50MG/ML | INJECTABLE;INJECTION | Prescription | Yes | AP | 050573 | NOVARTIS |