Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021443
Company: ASPEN
Company: ASPEN
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | 0.3MG | TABLET;ORAL | Discontinued | None | No | No |
ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | 0.45MG | TABLET;ORAL | Discontinued | None | No | No |
ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | 0.625MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | 1.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | No | No |
ENJUVIA | ESTROGENS, CONJUGATED SYNTHETIC B | 0.9MG | TABLET;ORAL | 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 |
---|---|---|---|---|---|---|---|
05/10/2004 | ORIG-1 | Approval | Type 3 - New Dosage Form | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021443lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21443ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021443s000_EnjuviaTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-13 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021443s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021443Orig1s013ltr.pdf | |
11/30/2020 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021443s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021443Orig1s011, s012ltr.pdf | |
11/30/2020 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021443s011s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/021443Orig1s011, s012ltr.pdf | |
11/01/2017 | SUPPL-10 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021443s010lbl.pdf | |
06/30/2015 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021443s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021443Orig1s009ltr.pdf | |
04/27/2007 | SUPPL-5 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021443s005ltr.pdf |
04/23/2007 | SUPPL-4 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021443s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021443s004ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-13 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021443s013lbl.pdf | |
11/30/2020 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021443s011s012lbl.pdf | |
11/30/2020 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/021443s011s012lbl.pdf | |
11/01/2017 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021443s010lbl.pdf | |
06/30/2015 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021443s009lbl.pdf | |
04/23/2007 | SUPPL-4 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021443s004lbl.pdf | |
05/10/2004 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021443lbl.pdf |