Drugs@FDA: FDA-Approved Drugs
Company: NOVARTIS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESTRADERM | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Discontinued | None | Yes | No |
| ESTRADERM | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | 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 |
|---|---|---|---|---|---|---|---|
| 09/10/1986 | 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 |
|---|---|---|---|---|---|
| 11/01/2017 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019081s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019081Orig1s043ltr.pdf | |
| 07/03/2012 | SUPPL-42 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019081s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019081s042ltr.pdf | |
| 12/17/2004 | SUPPL-40 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081s040ltr.pdf | |
| 05/28/2004 | SUPPL-39 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081slr036,039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019081_s036&s039_ESTRADERM.pdf | |
| 05/28/2004 | SUPPL-36 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19081slr036,039ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019081_s036&s039_ESTRADERM.pdf | |
| 03/14/2002 | SUPPL-35 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 08/20/2001 | SUPPL-34 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/10/1997 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 06/27/1996 | SUPPL-29 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/27/1996 | SUPPL-28 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 12/07/1995 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 11/28/1995 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 01/20/1995 | SUPPL-25 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/10/1995 | SUPPL-24 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 05/18/1994 | SUPPL-23 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 04/05/1993 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 08/09/1993 | SUPPL-21 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/22/1995 | SUPPL-20 | Labeling |
Label is not available on this site. |
||
| 01/22/1992 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/24/1991 | SUPPL-18 | Efficacy-New Indication |
Label is not available on this site. |
||
| 06/12/1990 | SUPPL-17 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/19/1990 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 06/18/1990 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/19/1990 | SUPPL-13 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 02/03/1989 | SUPPL-11 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/01/1988 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/25/1988 | SUPPL-9 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 04/28/1988 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/07/1987 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 01/07/1988 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1988 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1988 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1988 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/26/1987 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 12/03/1986 | 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 |
|---|---|---|---|---|---|
| 11/01/2017 | SUPPL-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019081s043lbl.pdf | |
| 07/03/2012 | SUPPL-42 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019081s042lbl.pdf | |
| 12/17/2004 | SUPPL-40 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081s040lbl.pdf | |
| 05/28/2004 | SUPPL-39 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf | |
| 05/28/2004 | SUPPL-36 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19081slr036,039_estraderm_lbl.pdf |