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
ALTAVERA از شرکت XIROMED
Abbreviated New Drug Application (ANDA): 079102
Company: XIROMED
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALTAVERA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | 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 |
|---|---|---|---|---|---|---|---|
| 08/03/2010 | 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 |
|---|---|---|---|---|---|
| 03/03/2020 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/09/2017 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/25/2014 | SUPPL-6 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/24/2011 | SUPPL-2 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
ALTAVERA
TABLET;ORAL-28; 0.03MG;0.15MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALTAVERA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 079102 | XIROMED |
| AYUNA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 206866 | AUROBINDO PHARMA LTD |
| KURVELO | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 091408 | LUPIN LTD |
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 201095 | AMNEAL PHARMS |
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 091663 | MYLAN LABS LTD |
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 207033 | NAARI PTE LTD |
| LEVORA 0.15/30-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 073594 | MAYNE PHARMA |
| MARLISSA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 091452 | GLENMARK GENERICS |
| PORTIA-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.03MG;0.15MG | TABLET;ORAL-28 | Prescription | No | AB | 075866 | BARR |
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