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
BLISOVI 24 FE از شرکت LUPIN LTD
Abbreviated New Drug Application (ANDA): 091398
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BLISOVI 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | 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 |
|---|---|---|---|---|---|---|---|
| 10/28/2015 | 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 |
|---|---|---|---|---|---|
| 11/15/2019 | SUPPL-14 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/01/2019 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/01/2019 | SUPPL-5 | Labeling-Package Insert, Labeling |
Label is not available on this site. |
||
| 05/01/2019 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
BLISOVI 24 FE
TABLET;ORAL; 0.02MG;1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AUROVELA 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 207504 | AUROBINDO PHARMA LTD |
| BLISOVI 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 091398 | LUPIN LTD |
| GILDESS 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 090293 | VINTAGE PHARMS |
| LARIN 24 FE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 202994 | NOVAST LABS |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 078267 | AMNEAL PHARMS |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 090938 | BARR LABS INC |
| NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE | ETHINYL ESTRADIOL; NORETHINDRONE ACETATE | 0.02MG;1MG | TABLET;ORAL | Prescription | No | AB | 204847 | GLENMARK PHARMS LTD |
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