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
AFIRMELLE از شرکت AUROBINDO PHARMA LTD
Abbreviated New Drug Application (ANDA): 206886
Company: AUROBINDO PHARMA LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AFIRMELLE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription |
AB1 |
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 |
|---|---|---|---|---|---|---|---|
| 11/14/2016 | ORIG-1 | Approval |
STANDARD |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-1 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
AFIRMELLE
TABLET;ORAL-28; 0.02MG;0.1MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| AFIRMELLE | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 206886 | AUROBINDO PHARMA LTD |
| AVIANE-28 | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 075796 | DURAMED PHARMS BARR |
| CERINTA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 202817 | SUN PHARM |
| FALMINA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 090721 | NOVAST LABS LTD |
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 201108 | AMNEAL PHARMS |
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 091425 | LUPIN LTD |
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 076625 | MAYNE PHARMA |
| LEVONORGESTREL AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 200245 | MYLAN LABS LTD |
| VIENVA | ETHINYL ESTRADIOL; LEVONORGESTREL | 0.02MG;0.1MG | TABLET;ORAL-28 | Prescription | No | AB1 | 201088 | XIROMED |
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