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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012802
Company: FOSUN PHARMA

Products on NDA 012802

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ARISTOCORT	TRIAMCINOLONE DIACETATE	40MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	INJECTABLE;INJECTION	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012802

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
09/05/1961	ORIG-1	Approval	Type 5 - New Formulation or New Manufacturer	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
06/05/2024	SUPPL-34	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/012802s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/012802Orig1s034ltr.pdf
07/03/2014	SUPPL-33	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012802s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/012802Orig1s033ltr.pdf
09/04/2014	SUPPL-32	Manufacturing (CMC)		Label is not available on this site.
01/14/2010	SUPPL-31	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012802s031lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/012802s031ltr.pdf
08/29/2001	SUPPL-28	Manufacturing (CMC)-Control		Label is not available on this site.
10/25/1999	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
11/09/1995	SUPPL-26	Manufacturing (CMC)-Control		Label is not available on this site.
08/04/1994	SUPPL-25	Manufacturing (CMC)-Control		Label is not available on this site.
09/07/1993	SUPPL-24	Labeling		Label is not available on this site.
01/06/1992	SUPPL-23	Manufacturing (CMC)-Control		Label is not available on this site.
11/05/1992	SUPPL-22	Manufacturing (CMC)-Control		Label is not available on this site.
01/22/1992	SUPPL-21	Manufacturing (CMC)-Control		Label is not available on this site.
10/12/1989	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
02/06/1992	SUPPL-17	Manufacturing (CMC)		Label is not available on this site.
01/17/2003	SUPPL-16	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12802slr016,%20014ltr.pdf
01/17/2003	SUPPL-14	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/12802slr016,%20014ltr.pdf
10/03/1980	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 012802

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/05/2024	SUPPL-34	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/012802s034lbl.pdf
07/03/2014	SUPPL-33	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/012802s033lbl.pdf
01/14/2010	SUPPL-31	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/012802s031lbl.pdf

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