Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020538
Company: SANDOZ
Company: SANDOZ
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | Film, Extended Release; Transdermal | Discontinued | None | No | No |
| ESTRADIOL | ESTRADIOL | 0.075MG/24HR | Film, Extended Release; Transdermal | Discontinued | None | No | No |
| ESTRADIOL | ESTRADIOL | 0.05MG/24HR | Film, Extended Release; Transdermal | Discontinued | None | No | No |
| ESTRADIOL | ESTRADIOL | 0.1MG/24HR | Film, Extended Release; Transdermal | Discontinued | None | No | No |
| VIVELLE-DOT | ESTRADIOL | 0.0375MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB1 | Yes | No |
| VIVELLE-DOT | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB1 | Yes | No |
| VIVELLE-DOT | ESTRADIOL | 0.075MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB1 | Yes | No |
| VIVELLE-DOT | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB1 | Yes | Yes |
| VIVELLE-DOT | ESTRADIOL | 0.025MG/24HR | SYSTEM;TRANSDERMAL | Prescription | AB1 | 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 |
|---|---|---|---|---|---|---|---|
| 07/31/1996 | 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 |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-43 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020538s043lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020538Orig1s043ltr.pdf | |
| 09/01/2021 | SUPPL-40 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020538Orig1s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020538s040ltr.pdf | |
| 10/04/2021 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020538s037;s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020538Orig1s037, s039ltr.pdf | |
| 10/04/2021 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020538s037;s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/020538Orig1s037, s039ltr.pdf | |
| 11/01/2017 | SUPPL-35 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020538s035lbl.pdf | |
| 09/01/2015 | SUPPL-33 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/31/2014 | SUPPL-32 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020538s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020538Orig1s032ltr.pdf | |
| 04/24/2013 | SUPPL-31 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/20/2013 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s030ltr.pdf | |
| 05/20/2013 | SUPPL-29 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s030ltr.pdf | |
| 05/20/2013 | SUPPL-28 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020538Orig1s028,s029,s030ltr.pdf | |
| 08/06/2004 | SUPPL-24 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20538s024ltr.pdf | |
| 01/28/2004 | SUPPL-19 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538slr019_vivelle_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20538slr019ltr.pdf | |
| 03/28/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/22/2002 | SUPPL-16 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/03/2002 | SUPPL-15 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020538_s015_VivelleTOC.cfm | |
| 05/03/2002 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf | |
| 07/09/2001 | SUPPL-13 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/03/2002 | SUPPL-12 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20538s012ltr.pdf | |
| 09/29/2000 | SUPPL-10 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/29/1999 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/26/1999 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 07/30/1999 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/08/1999 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_prntlbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_appltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538S6.cfm | |
| 09/26/1997 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/25/1997 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/23/1997 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/15/1997 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/15/1997 | 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-43 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020538s043lbl.pdf | |
| 10/04/2021 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020538s037;s039lbl.pdf | |
| 10/04/2021 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020538s037;s039lbl.pdf | |
| 09/01/2021 | SUPPL-40 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/020538Orig1s040lbl.pdf | |
| 11/01/2017 | SUPPL-35 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020538s035lbl.pdf | |
| 07/31/2014 | SUPPL-32 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020538s032lbl.pdf | |
| 05/20/2013 | SUPPL-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf | |
| 05/20/2013 | SUPPL-29 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf | |
| 05/20/2013 | SUPPL-28 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020538s028s029s030lbl.pdf | |
| 08/06/2004 | SUPPL-24 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538s024lbl.pdf | |
| 01/28/2004 | SUPPL-19 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20538slr019_vivelle_lbl.pdf | |
| 05/03/2002 | SUPPL-15 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf | |
| 05/03/2002 | SUPPL-14 | Efficacy-Labeling Change With Clinical Data | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf | |
| 05/03/2002 | SUPPL-12 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20538s12s14s15lbl.pdf | |
| 01/08/1999 | SUPPL-6 | Manufacturing (CMC)-Formulation | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20538s6_prntlbl.pdf |
ESTRADIOL
There are no Therapeutic Equivalents.
VIVELLE-DOT
SYSTEM;TRANSDERMAL; 0.0375MG/24HR
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 211293 | AMNEAL |
| ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 201675 | MYLAN TECHNOLOGIES |
| ESTRADIOL | ESTRADIOL | 0.0375MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 206241 | ZYDUS PHARMS |
| VIVELLE-DOT | ESTRADIOL | 0.0375MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB1 | 020538 | SANDOZ |
SYSTEM;TRANSDERMAL; 0.05MG/24HR
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 211293 | AMNEAL |
| ESTRADIOL | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 201675 | MYLAN TECHNOLOGIES |
| ESTRADIOL | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 206241 | ZYDUS PHARMS |
| VIVELLE-DOT | ESTRADIOL | 0.05MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB1 | 020538 | SANDOZ |
SYSTEM;TRANSDERMAL; 0.075MG/24HR
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | 0.075MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 211293 | AMNEAL |
| ESTRADIOL | ESTRADIOL | 0.075MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 201675 | MYLAN TECHNOLOGIES |
| ESTRADIOL | ESTRADIOL | 0.075MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 206241 | ZYDUS PHARMS |
| VIVELLE-DOT | ESTRADIOL | 0.075MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB1 | 020538 | SANDOZ |
SYSTEM;TRANSDERMAL; 0.1MG/24HR
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 211293 | AMNEAL |
| ESTRADIOL | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 201675 | MYLAN TECHNOLOGIES |
| ESTRADIOL | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 206241 | ZYDUS PHARMS |
| VIVELLE-DOT | ESTRADIOL | 0.1MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB1 | 020538 | SANDOZ |
SYSTEM;TRANSDERMAL; 0.025MG/24HR
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | 0.025MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 211293 | AMNEAL |
| ESTRADIOL | ESTRADIOL | 0.025MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 201675 | MYLAN TECHNOLOGIES |
| ESTRADIOL | ESTRADIOL | 0.025MG/24HR | SYSTEM;TRANSDERMAL | Prescription | No | AB1 | 206241 | ZYDUS PHARMS |
| VIVELLE-DOT | ESTRADIOL | 0.025MG/24HR | SYSTEM;TRANSDERMAL | Prescription | Yes | AB1 | 020538 | SANDOZ |