Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020992
Company: ASPEN
Company: ASPEN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CENESTIN | ESTROGENS, CONJUGATED SYNTHETIC A | 0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CENESTIN | ESTROGENS, CONJUGATED SYNTHETIC A | 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CENESTIN | ESTROGENS, CONJUGATED SYNTHETIC A | 0.9MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CENESTIN | ESTROGENS, CONJUGATED SYNTHETIC A | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| CENESTIN | ESTROGENS, CONJUGATED SYNTHETIC A | 0.45MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 03/24/1999 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20992lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20992ltr.htm https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20992.cfm |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 02/15/2024 | SUPPL-41 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020992s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/020992Orig1s041ltr.pdf | |
| 11/30/2020 | SUPPL-39 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020992s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020992Orig1s038, s039ltr.pdf | |
| 11/30/2020 | SUPPL-38 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020992s038s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/020992Orig1s038, s039ltr.pdf | |
| 11/01/2017 | SUPPL-37 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020992s037lbl.pdf | |
| 03/20/2015 | SUPPL-34 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020992s034lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020992Orig1s034ltr.pdf | |
| 10/28/2004 | SUPPL-26 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20992s026lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992s026ltr.pdf | |
| 01/28/2004 | SUPPL-24 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992slr024ltr.pdf |
| 11/05/2002 | SUPPL-23 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/18/2002 | SUPPL-22 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/05/2004 | SUPPL-21 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20992se2-021_cenestin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992se2-021ltr.pdf | |
| 04/29/2002 | SUPPL-20 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/05/2002 | SUPPL-19 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/2002 | SUPPL-18 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/08/2002 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 06/21/2002 | SUPPL-16 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20992s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20992s016LTR.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020992_S016_CENESTINTOC.cfm | |
| 09/05/2001 | SUPPL-15 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/10/2001 | SUPPL-14 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-13 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 07/20/2001 | SUPPL-12 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/22/2002 | SUPPL-11 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20992s11ltr.pdf |
| 08/09/2000 | SUPPL-9 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/27/2000 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 03/13/2000 | SUPPL-6 | Manufacturing (CMC)-Formulation |
Label is not available on this site. |
||
| 01/07/2000 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/08/1999 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/12/1999 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/02/1999 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 09/07/1999 | 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-41 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020992s041lbl.pdf | |
| 11/30/2020 | SUPPL-39 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020992s038s039lbl.pdf | |
| 11/30/2020 | SUPPL-38 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/020992s038s039lbl.pdf | |
| 11/01/2017 | SUPPL-37 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020992s037lbl.pdf | |
| 03/20/2015 | SUPPL-34 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020992s034lbl.pdf | |
| 10/28/2004 | SUPPL-26 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20992s026lbl.pdf | |
| 02/05/2004 | SUPPL-21 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20992se2-021_cenestin_lbl.pdf | |
| 06/21/2002 | SUPPL-16 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20992s16lbl.pdf | |
| 03/24/1999 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20992lbl.pdf |