Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 018202
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CYTADREN AMINOGLUTETHIMIDE 250MG TABLET;ORAL Discontinued None No No
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.

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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