اطلاعات داروی نمایش داده شده مستقیما از دیتابیس اطلاعات دارویی سازمان غذا و دارو آمریکا (FDA) استخراج می شود و مرتبا به روز رسانی می شود
داروی نمایش داده شده مورد تایید FDA می باشد و اطلاعات ثبت آن در زیر قابل مشاهده است
CLIMARA PRO از شرکت BAYER HLTHCARE
New Drug Application (NDA): 021258
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 |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/021258lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 11/01/2017 | SUPPL-11 | Labeling-Package Insert |
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 |
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 |
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 |
|---|---|---|---|---|---|
| 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 |
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