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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018554
Company: SCHERING

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EULEXIN FLUTAMIDE 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CAPSULE;ORAL Discontinued None Yes No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
01/27/1989 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
07/23/2001 SUPPL-23 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18554s23lbl.pdf
03/30/2001 SUPPL-22 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18554S22LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18554_S022.pdf
03/23/2001 SUPPL-21 Labeling Letter (PDF)
Review (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/18554S21LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/18554_S021.pdf
03/14/2001 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.
01/23/2001 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.
01/07/2000 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.
05/18/1998 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
11/12/1997 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
08/19/1999 SUPPL-15 Labeling

Label is not available on this site.
06/21/1996 SUPPL-14 Efficacy-New Indication

Label is not available on this site.
11/15/1995 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
09/15/1995 SUPPL-12 Labeling

Label is not available on this site.
10/26/1994 SUPPL-11 Labeling

Label is not available on this site.
09/19/1991 SUPPL-10 Labeling

Label is not available on this site.
05/18/1992 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
07/22/1993 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
05/07/1991 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
08/30/1996 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
09/03/1990 SUPPL-3 Labeling

Label is not available on this site.
07/29/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
10/17/1989 SUPPL-1 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
07/23/2001 SUPPL-23 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/18554s23lbl.pdf
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