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
AMABELZ از شرکت LUPIN LTD
Abbreviated New Drug Application (ANDA): 203339
Company: LUPIN LTD
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| AMABELZ | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription |
AB |
No | No |
| AMABELZ | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | 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 |
|---|---|---|---|---|---|---|---|
| 06/20/2016 | 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 |
|---|---|---|---|---|---|
| 04/21/2017 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
AMABELZ
TABLET;ORAL; 0.5MG;0.1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | Yes | AB | 020907 | AMNEAL |
| AMABELZ | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | No | AB | 203339 | LUPIN LTD |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | No | AB | 078324 | BRECKENRIDGE PHARM |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | No | AB | 207261 | MYLAN LABS LTD |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 0.5MG;0.1MG | TABLET;ORAL | Prescription | No | AB | 210612 | NOVAST LABS |
TABLET;ORAL; 1MG;0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACTIVELLA | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | Yes | AB | 020907 | AMNEAL |
| AMABELZ | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 203339 | LUPIN LTD |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 079193 | BARR |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 078324 | BRECKENRIDGE PHARM |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 207261 | MYLAN LABS LTD |
| ESTRADIOL AND NORETHINDRONE ACETATE | ESTRADIOL; NORETHINDRONE ACETATE | 1MG;0.5MG | TABLET;ORAL | Prescription | No | AB | 210612 | NOVAST LABS |
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