Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 021256
Company: CHIRHOCLIN
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CHIRHOSTIM SECRETIN SYNTHETIC HUMAN 16MCG/VIAL FOR SOLUTION;INTRAVENOUS Prescription None Yes Yes
CHIRHOSTIM SECRETIN SYNTHETIC HUMAN 40MCG/VIAL FOR SOLUTION;INTRAVENOUS Prescription None Yes 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
04/09/2004 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21256_humansecretin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21256ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/21-256_SyntheticHS.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/18/2017 SUPPL-13 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021256s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021256Orig1s013ltr.pdf
07/28/2015 SUPPL-12 Manufacturing (CMC)

Label is not available on this site.

06/21/2007 SUPPL-4 Manufacturing (CMC)-Control Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021256s004ltr.pdf
06/21/2007 SUPPL-2 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021256s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021256s002ltr.pdf
09/07/2004 SUPPL-1 Labeling Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21256s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/18/2017 SUPPL-13 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021256s013lbl.pdf
06/21/2007 SUPPL-2 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021256s002lbl.pdf
04/09/2004 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21256_humansecretin_lbl.pdf

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