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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019579
Company: JANSSEN PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TERAZOL 7 TERCONAZOLE 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM;VAGINAL Discontinued None Yes No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
12/31/1987 ORIG-1 Approval Type 1 - New Molecular Entity 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
07/23/2014 SUPPL-37 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,019964s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/019579Orig1s037,019641Orig1s030,019964Orig1s032ltr.pdf
07/23/2013 SUPPL-36 Manufacturing (CMC)

Label is not available on this site.
09/26/2013 SUPPL-35 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,019964s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/2013/019579Orig1s035,019641s028,019964Orig1s030ltr.pdf
06/30/2004 SUPPL-26 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19579slr026,19641slr022,19964slr021ltr.pdf
09/24/2003 SUPPL-25 Labeling Letter (PDF)

Label is not available on this site.

 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr025,19964slr020ltr.pdf
10/04/2002 SUPPL-22 Manufacturing (CMC)-Control

Label is not available on this site.
12/10/2001 SUPPL-21 Manufacturing (CMC)-Control

Label is not available on this site.
03/11/2003 SUPPL-20 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf
09/21/2001 SUPPL-19 Manufacturing (CMC)-Control

Label is not available on this site.
03/13/2001 SUPPL-18 Manufacturing (CMC)-Packaging

Label is not available on this site.
02/22/2000 SUPPL-17 Manufacturing (CMC)-Control

Label is not available on this site.
03/11/2003 SUPPL-16 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19579slr016,020,19641slr016,018,19964slr011,014ltr.pdf
10/08/1999 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
10/08/1999 SUPPL-14 Manufacturing (CMC)

Label is not available on this site.
11/01/1999 SUPPL-13 Manufacturing (CMC)

Label is not available on this site.
10/07/1998 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/28/1997 SUPPL-10 Labeling

Label is not available on this site.
10/17/1994 SUPPL-9 Manufacturing (CMC)-Control

Label is not available on this site.
02/09/1993 SUPPL-8 Manufacturing (CMC)-Control

Label is not available on this site.
09/24/1992 SUPPL-7 Manufacturing (CMC)

Label is not available on this site.
08/21/1990 SUPPL-6 Manufacturing (CMC)-Control

Label is not available on this site.
08/21/1990 SUPPL-5 Manufacturing (CMC)

Label is not available on this site.
07/28/1989 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
12/06/1989 SUPPL-3 Labeling

Label is not available on this site.
04/03/1989 SUPPL-2 Manufacturing (CMC)-Expiration Date

Label is not available on this site.
12/06/1989 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
07/23/2014 SUPPL-37 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,019964s032lbl.pdf
09/26/2013 SUPPL-35 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,019964s030lbl.pdf
06/30/2004 SUPPL-26 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf
03/11/2003 SUPPL-20 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf
03/11/2003 SUPPL-16 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf
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