Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021136
Company: CHIRHOCLIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SECREFLO SECRETIN SYNTHETIC PORCINE 16MCG/VIAL FOR 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
04/04/2002 ORIG-1 Approval Type 3 - New Dosage Form STANDARD; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21136lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21136ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-136_21-209_SecreFlo.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/26/2016 SUPPL-13 Labeling-Container/Carton Labels Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013_021209s002lbl.pdf
10/26/2016 SUPPL-12 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013_021209s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021136Orig1s012,021209Orig1s001ltr.pdf
09/12/2005 SUPPL-11 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021136s011ltr.pdf
07/26/2004 SUPPL-9 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21136s009ltr.pdf
03/01/2004 SUPPL-6 Manufacturing (CMC)-Formulation Letter (PDF)
Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21136scf006ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021136_S006_SECRETFLO_INJ.pdf
03/01/2004 SUPPL-5 Manufacturing (CMC) Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21136scm005ltr.pdf
11/01/2002 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21136s1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21136se1-001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021136_S001_SECRETFLO_INJ.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/26/2016 SUPPL-13 Labeling-Container/Carton Labels Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013_021209s002lbl.pdf
10/26/2016 SUPPL-12 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013_021209s002lbl.pdf
11/01/2002 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21136s1lbl.pdf
04/04/2002 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21136lbl.pdf

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