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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018202
Company: NOVARTIS

Products on NDA 018202

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYTADREN	AMINOGLUTETHIMIDE	250MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 018202

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
10/29/1980	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2003	SUPPL-21	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018202s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18202slr021ltr.pdf
05/13/2002	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
01/25/2002	SUPPL-19	Manufacturing (CMC)		Label is not available on this site.
08/01/2000	SUPPL-18	Manufacturing (CMC)		Label is not available on this site.
04/23/1999	SUPPL-17	Manufacturing (CMC)-Packaging		Label is not available on this site.
03/18/1999	SUPPL-16	Manufacturing (CMC)		Label is not available on this site.
04/15/1998	SUPPL-15	Labeling		Label is not available on this site.
03/23/1995	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
01/14/1994	SUPPL-13	Manufacturing (CMC)		Label is not available on this site.
08/04/1992	SUPPL-12	Manufacturing (CMC)-Control		Label is not available on this site.
07/27/1993	SUPPL-11	Labeling		Label is not available on this site.
08/14/1984	SUPPL-9	Manufacturing (CMC)-Control		Label is not available on this site.
11/09/1984	SUPPL-8	Labeling		Label is not available on this site.
08/16/1984	SUPPL-6	Manufacturing (CMC)-Control		Label is not available on this site.
12/02/1981	SUPPL-4	Manufacturing (CMC)-Packaging		Label is not available on this site.
12/02/1981	SUPPL-3	Labeling		Label is not available on this site.

Labels for NDA 018202

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/07/2003	SUPPL-21	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018202s021lbl.pdf

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