Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 022028
Company: SANDOZ INC
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
COSYNTROPIN COSYNTROPIN 0.25MG/ML (0.25MG/ML) SOLUTION;INTRAVENOUS Discontinued 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
02/21/2008 ORIG-1 Approval Type 5 - New Formulation or New Manufacturer STANDARD Label (PDF)
Letter (PDF)
Review
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/022028s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022028_cosyntropin_toc.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/022028s000_SumR.pdf
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
05/11/2018 SUPPL-5 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022028s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/022028Orig1s005ltr.pdf
08/07/2013 SUPPL-4 Manufacturing (CMC)

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
05/11/2018 SUPPL-5 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022028s005lbl.pdf
02/21/2008 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/022028lbl.pdf

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