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
BRIELLYN از شرکت GLENMARK GENERICS
Abbreviated New Drug Application (ANDA): 090538
Company: GLENMARK GENERICS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BRIELLYN | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | 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 |
|---|---|---|---|---|---|---|---|
| 03/22/2011 | 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 |
|---|---|---|---|---|---|
| 08/09/2017 | SUPPL-3 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 02/25/2014 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |
BRIELLYN
TABLET;ORAL-28; 0.035MG;0.4MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BALZIVA-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | Prescription | No | AB | 076238 | BARR |
| BRIELLYN | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | Prescription | No | AB | 090538 | GLENMARK GENERICS |
| GILDAGIA | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | Prescription | No | AB | 078376 | VINTAGE PHARMS |
| NORETHINDRONE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | Prescription | No | AB | 078323 | WATSON LABS |
| PHILITH | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | Prescription | No | AB | 090947 | NOVAST LABS LTD |
| VYFEMLA | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;0.4MG | TABLET;ORAL-28 | Prescription | No | AB | 201886 | LUPIN LTD |
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