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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021136
Company: CHIRHOCLIN

Products on NDA 021136

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021136

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

Labels for NDA 021136

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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