Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021355
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
ANGELIQ | DROSPIRENONE; ESTRADIOL | 0.25MG;0.5MG | TABLET;ORAL | Prescription | None | Yes | No |
ANGELIQ | DROSPIRENONE; ESTRADIOL | 0.5MG;1MG | TABLET;ORAL | Prescription | None | 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 |
---|---|---|---|---|---|---|---|
09/28/2005 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021355lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021355ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021355s000TOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021355s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/021355Orig1s012ltr.pdf | |
10/02/2023 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021355s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021355Orig1s009;s010ltr.pdf | |
10/02/2023 | SUPPL-9 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021355s009s010lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/021355Orig1s009;s010ltr.pdf | |
11/01/2017 | SUPPL-8 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021355s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/021355Orig1s008ltr.pdf | |
06/30/2015 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021355s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021355Orig1s006ltr.pdf | |
01/26/2015 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
02/29/2012 | SUPPL-3 | Efficacy-New Dosing Regimen |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021355s003ltr.pdf | |
02/29/2012 | SUPPL-2 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021355s002ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021355s012lbl.pdf | |
10/02/2023 | SUPPL-10 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021355s009s010lbl.pdf | |
10/02/2023 | SUPPL-10 | Labeling-Patient Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021355s009s010lbl.pdf | |
10/02/2023 | SUPPL-9 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/021355s009s010lbl.pdf | |
11/01/2017 | SUPPL-8 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021355s008lbl.pdf | |
06/30/2015 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021355s006lbl.pdf | |
02/29/2012 | SUPPL-3 | Efficacy-New Dosing Regimen | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s003lbl.pdf | |
02/29/2012 | SUPPL-2 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/021355s002lbl.pdf | |
09/28/2005 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021355lbl.pdf |