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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 011685
Company: FOSUN PHARMA

Products on NDA 011685

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARISTOCORT	TRIAMCINOLONE DIACETATE	25MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 011685

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/12/1959	ORIG-1	Approval	Type 2 - New Active Ingredient	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/03/2014	SUPPL-26	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011685s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/011685Orig1s026ltr.pdf
08/29/2001	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
10/25/1999	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
11/09/1995	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
08/04/1994	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
09/07/1993	SUPPL-20	Labeling		Label is not available on this site.
02/06/1992	SUPPL-19	Manufacturing (CMC)-Control		Label is not available on this site.
11/05/1992	SUPPL-18	Manufacturing (CMC)-Control		Label is not available on this site.
10/12/1989	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/06/1992	SUPPL-14	Manufacturing (CMC)		Label is not available on this site.
10/06/1980	SUPPL-12	Manufacturing (CMC)-Formulation		Label is not available on this site.

Labels for NDA 011685

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
07/03/2014	SUPPL-26	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/011685s026lbl.pdf

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