Drugs@FDA: FDA-Approved Drugs
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TERAZOL 3 | TERCONAZOLE | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM;VAGINAL | Discontinued | None | Yes | No |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. |
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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 |