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
BEYAZ از شرکت BAYER HLTHCARE
New Drug Application (NDA): 022532
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BEYAZ | DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM | 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | TABLET;ORAL | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 09/24/2010 | ORIG-1 | Approval |
Type 4 – New Combination |
STANDARD |
|
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022532s000lbl.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-9 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022532s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/022532Orig1s009ltr.pdf |
||
| 05/11/2016 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 06/01/2015 | SUPPL-6 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022532s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021098Orig1s023,022532Orig1s006,022574Orig1s006,021676Orig1s014ltr.pdf |
||
| 04/10/2012 | SUPPL-4 | Labeling-Package Insert |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/021098s022,021676s012,022532s004,022574s004ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022532Orig1s004.pdf |
||
| 02/13/2012 | SUPPL-1 | Efficacy-Labeling Change With Clinical Data |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/022532s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/022532Orig1s001.pdf |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-9 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/022532s009lbl.pdf | |
| 06/01/2015 | SUPPL-6 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022532s006lbl.pdf | |
| 04/10/2012 | SUPPL-4 |
Labeling-Package Insert |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s004lbl.pdf | |
| 02/13/2012 | SUPPL-1 |
Efficacy-Labeling Change With Clinical Data |
Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022532s001lbl.pdf | |
| 09/24/2010 | ORIG-1 | Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022532s000lbl.pdf |
BEYAZ
TABLET;ORAL; 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BEYAZ | DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM | 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | TABLET;ORAL | Prescription | Yes | AB | 022532 | BAYER HLTHCARE |
| DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM | DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM | 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | TABLET;ORAL | Prescription | No | AB | 205947 | LUPIN LTD |
| DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM | DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM | 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG | TABLET;ORAL | Prescription | No | AB | 203593 | WATSON LABS INC |
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