Drugs@FDA: FDA-Approved Drugs
Company: SANDOZ
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
VIVELLE | ESTRADIOL | 0.0375MG/24HR | SYSTEM;TRANSDERMAL | Discontinued | None | No | No |
VIVELLE | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Discontinued | None | No | No |
VIVELLE | ESTRADIOL | 0.075MG/24HR | SYSTEM;TRANSDERMAL | Discontinued | None | No | No |
VIVELLE | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Discontinued | None | No | No |
VIVELLE | ESTRADIOL | 0.025MG/24HR | SYSTEM;TRANSDERMAL | 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 |
---|---|---|---|---|---|---|---|
10/28/1994 | ORIG-1 | Approval | Type 3 - New Dosage Form | 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 |
---|---|---|---|---|---|
02/15/2024 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020323s038lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020323Orig1s038ltr.pdf | |
11/01/2017 | SUPPL-36 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020323s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020323Orig1s036ltr.pdf | |
08/06/2004 | SUPPL-33 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323s033ltr.pdf | |
01/22/2004 | SUPPL-30 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr.pdf | |
07/18/2002 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/28/2002 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/31/2001 | SUPPL-27 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/03/2001 | SUPPL-26 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/22/2004 | SUPPL-25 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr.pdf | |
02/01/2001 | SUPPL-24 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
08/16/2000 | SUPPL-23 | Labeling |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S23ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-167_20-323S23_Vivelle.cfm | |
10/29/1999 | SUPPL-22 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/25/2000 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S21LBL.PDF https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S21LTR.PDF https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-323S021_Vivelle.cfm | |
04/01/1999 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
10/27/1998 | SUPPL-19 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/28/1998 | SUPPL-18 | Manufacturing (CMC) |
Label is not available on this site. |
||
01/22/2004 | SUPPL-17 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr.pdf | |
07/23/1997 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
07/22/1997 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
05/29/1997 | SUPPL-14 | Labeling |
Label is not available on this site. |
||
07/10/1996 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
01/09/1997 | SUPPL-12 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
02/21/1996 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/21/1996 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
12/07/1995 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
12/11/1995 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
04/10/1996 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
08/09/1995 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
06/20/1995 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/02/1995 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
06/09/1995 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
03/21/1995 | 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 |
---|---|---|---|---|---|
02/15/2024 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020323s038lbl.pdf | |
11/01/2017 | SUPPL-36 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020323s036lbl.pdf | |
08/06/2004 | SUPPL-33 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323s033lbl.pdf | |
01/22/2004 | SUPPL-30 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf | |
01/22/2004 | SUPPL-25 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf | |
01/22/2004 | SUPPL-17 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf | |
08/16/2000 | SUPPL-23 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf | |
02/25/2000 | SUPPL-21 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S21LBL.PDF |