Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 021258
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLIMARA PRO | ESTRADIOL; LEVONORGESTREL | 0.045MG/24HR;0.015MG/24HR | FILM, EXTENDED RELEASE;TRANSDERMAL | 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 |
---|---|---|---|---|---|---|---|
11/21/2003 | ORIG-1 | Approval | Type 4 - New Combination | STANDARD |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021258lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21258ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/021258s000_ClimaraTOC.cfm |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-15 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021258s015lbl.pdf | |
10/07/2021 | SUPPL-13 | Labeling-Container/Carton Labels |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021258Orig1s013ltr.pdf |
11/15/2021 | SUPPL-12 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021258s012lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/021258orig1s012ltr.pdf | |
11/01/2017 | SUPPL-11 | Labeling-Package Insert |
Label (PDF)
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021258s011lbl.pdf | |
03/08/2016 | SUPPL-10 | Manufacturing (CMC) |
Label is not available on this site. |
||
10/09/2013 | SUPPL-6 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021258s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021258Orig1s006ltr.pdf | |
06/22/2005 | SUPPL-3 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021258s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021258s003ltr.pdf |
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
---|---|---|---|---|---|
02/15/2024 | SUPPL-15 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021258s015lbl.pdf | |
11/15/2021 | SUPPL-12 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021258s012lbl.pdf | |
11/01/2017 | SUPPL-11 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/021258s011lbl.pdf | |
10/09/2013 | SUPPL-6 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021258s006lbl.pdf | |
06/22/2005 | SUPPL-3 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021258s003lbl.pdf | |
11/21/2003 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021258lbl.pdf |