Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 050738
Company: NOVARTIS
Company: NOVARTIS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
NEORAL | CYCLOSPORINE | 25MG | CAPSULE; ORAL | Prescription | None | No | No |
NEORAL | CYCLOSPORINE | 100MG | CAPSULE; ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
06/19/1997 | ORIG-1 | Approval | Type 6 - New Indication (no longer used) | STANDARD |
Label is not available on this site. |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
09/26/2023 | SUPPL-1 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050715s041,050716s041,050735s003,050736s001,050737s003,050738s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/050715Orig1s041,050716Orig1s041,050735Orig1s003,050736Orig1s001,050737Orig1s003,050738Orig1s001ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
09/26/2023 | SUPPL-1 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/050715s041,050716s041,050735s003,050736s001,050737s003,050738s001lbl.pdf |