Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020908
Company: NOVO NORDISK INC
Company: NOVO NORDISK INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| VAGIFEM | ESTRADIOL | 25MCG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;VAGINAL | Discontinued | None | Yes | No |
| VAGIFEM | ESTRADIOL | 10MCG | TABLET;VAGINAL | Prescription | AB | Yes | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 03/26/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20908lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20908ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020908_000_VagifemTOC.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-30 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020908s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020908Orig1s030ltr.pdf | |
| 12/04/2023 | SUPPL-29 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020908s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/020908Orig1s029ltr.pdf | |
| 09/29/2022 | SUPPL-27 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020908s027lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/020908Orig1s027ltr.pdf | |
| 04/09/2019 | SUPPL-26 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020908s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/020908Orig1s026ltr.pdf | |
| 11/01/2017 | SUPPL-25 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020908s025lbl.pdf | |
| 03/01/2017 | SUPPL-24 | Labeling-Container/Carton Labels |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020908s024lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020908Orig1s024ltr.pdf | |
| 04/04/2016 | SUPPL-23 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/27/2016 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/12/2015 | SUPPL-21 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 11/09/2012 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/11/2012 | SUPPL-17 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020908s017lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020908s017ltr.pdf | |
| 05/17/2011 | SUPPL-16 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020908s016ltr.pdf |
| 11/25/2009 | SUPPL-13 | Efficacy-New Dosing Regimen |
Label (PDF)
Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020908s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/020908Orig1s013.pdf | |
| 11/06/2002 | SUPPL-8 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/2002 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 07/12/2002 | SUPPL-6 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 09/06/2001 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/17/2001 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/14/2000 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 05/11/2000 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/03/1999 | SUPPL-1 | Manufacturing (CMC) |
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-30 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020908s030lbl.pdf | |
| 12/04/2023 | SUPPL-29 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/020908s029lbl.pdf | |
| 09/29/2022 | SUPPL-27 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020908s027lbl.pdf | |
| 09/29/2022 | SUPPL-27 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/020908s027lbl.pdf | |
| 04/09/2019 | SUPPL-26 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/020908s026lbl.pdf | |
| 11/01/2017 | SUPPL-25 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020908s025lbl.pdf | |
| 11/01/2017 | SUPPL-25 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020908s025lbl.pdf | |
| 03/01/2017 | SUPPL-24 | Labeling-Container/Carton Labels | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020908s024lbl.pdf | |
| 04/11/2012 | SUPPL-17 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020908s017lbl.pdf | |
| 11/25/2009 | SUPPL-13 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020908s013lbl.pdf | |
| 03/26/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20908lbl.pdf |
VAGIFEM
TABLET;VAGINAL; 10MCG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ESTRADIOL | ESTRADIOL | 10MCG | TABLET;VAGINAL | Prescription | No | AB | 205256 | AMNEAL PHARMS |
| ESTRADIOL | ESTRADIOL | 10MCG | TABLET;VAGINAL | Prescription | No | AB | 210264 | GLENMARK PHARMS LTD |
| ESTRADIOL | ESTRADIOL | 10MCG | TABLET;VAGINAL | Prescription | No | AB | 206388 | TEVA PHARMS USA |
| VAGIFEM | ESTRADIOL | 10MCG | TABLET;VAGINAL | Prescription | Yes | AB | 020908 | NOVO NORDISK INC |