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
BEKYREE از شرکت LUPIN LTD
Abbreviated New Drug Application (ANDA): 202226
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BEKYREE | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription |
AB |
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 |
|---|---|---|---|---|---|---|---|
| 08/12/2015 | ORIG-1 | Approval |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/30/2020 | SUPPL-7 | Labeling-Container/Carton Labels, Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/30/2020 | SUPPL-4 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2017 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
BEKYREE
TABLET;ORAL-28; 0.15MG,N/A;0.02MG,0.01MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BEKYREE | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription | No | AB | 202226 | LUPIN LTD |
| DESOGESTREL AND ETHINYL ESTRADIOL | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription | No | AB | 076916 | MAYNE PHARMA |
| DESOGESTREL AND ETHINYL ESTRADIOL | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription | No | AB | 202296 | MYLAN LABS LTD |
| DESOGESTREL AND ETHINYL ESTRADIOL | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription | No | AB | 209170 | NAARI PTE LTD |
| KARIVA | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription | No | AB | 075863 | BARR |
| KIMIDESS | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription | No | AB | 076681 | VINTAGE PHARMS |
| PIMTREA | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription | No | AB | 091247 | NOVAST LABS |
| SIMLIYA | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription | No | AB | 206853 | AUROBINDO PHARMA LTD |
| VIORELE | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription | No | AB | 091346 | GLENMARK GENERICS |
| VOLNEA | DESOGESTREL; ETHINYL ESTRADIOL | 0.15MG,N/A;0.02MG,0.01MG | TABLET;ORAL-28 | Prescription | No | AB | 202689 | XIROMED |
حتما بخوانید : CALDEROL از شرکت ORGANON USA INC
منبع : www.accessdata.fda.gov
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