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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050736
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
05/22/1997 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
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