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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021256
Company: CHIRHOCLIN

Products on NDA 021256

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021256

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

Labels for NDA 021256

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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