Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 021209
Company: CHIRHOCLIN

Products on NDA 021209

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PORCINE SECRETIN	PORCINE SECRETIN	16MCG	INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER	Prescription	None	No	No
PORCINE SECRETIN	PORCINE SECRETIN	40MCG	INJECTABLE;SUBCUTANEOUS LYOPHILIZED POWER	Prescription	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 021209

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 6 - New Indication (no longer used)	PRIORITY; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013,021209s002lbl.pdf
10/26/2016	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for NDA 021209

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/26/2016	SUPPL-2	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021136s012s013,021209s002lbl.pdf