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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019964
Company: JANSSEN PHARMS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
TERAZOL 3 TERCONAZOLE 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM;VAGINAL Discontinued None Yes No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
02/21/1991 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
07/23/2014 SUPPL-32 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-31 Manufacturing (CMC)

Label is not available on this site.
09/26/2013 SUPPL-30 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/appletter/2013/019579Orig1s035,019641s028,019964Orig1s030ltr.pdf
06/30/2004 SUPPL-21 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-20 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-17 Manufacturing (CMC)-Control

Label is not available on this site.
04/16/2002 SUPPL-16 Manufacturing (CMC)-Control

Label is not available on this site.
12/10/2001 SUPPL-15 Manufacturing (CMC)-Control

Label is not available on this site.
03/11/2003 SUPPL-14 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-13 Manufacturing (CMC)-Control

Label is not available on this site.
03/13/2001 SUPPL-12 Manufacturing (CMC)-Packaging

Label is not available on this site.
03/11/2003 SUPPL-11 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-10 Manufacturing (CMC)-Control

Label is not available on this site.
10/08/1999 SUPPL-9 Manufacturing (CMC)

Label is not available on this site.
10/28/1999 SUPPL-8 Manufacturing (CMC)

Label is not available on this site.
10/07/1998 SUPPL-7 Manufacturing (CMC)-Packaging

Label is not available on this site.
07/28/1997 SUPPL-6 Labeling

Label is not available on this site.
10/17/1994 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.
02/09/1993 SUPPL-4 Manufacturing (CMC)-Control

Label is not available on this site.
09/25/1992 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.
03/11/1992 SUPPL-1 Manufacturing (CMC)-Control

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-32 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/019579s037,019641s030,019964s032lbl.pdf
09/26/2013 SUPPL-30 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019579s035,019641s028,019964s030lbl.pdf
06/30/2004 SUPPL-21 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19579slr026,19641slr022,19964slr021_terazol_lbl.pdf
03/11/2003 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf
03/11/2003 SUPPL-11 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019641s016lbl.pdf
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