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
ALYACEN 1/35 از شرکت GLENMARK GENERICS
Abbreviated New Drug Application (ANDA): 091634
Company: GLENMARK GENERICS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ALYACEN 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | 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 |
|---|---|---|---|---|---|---|---|
| 01/19/2012 | ORIG-1 | Approval |
Not Applicable |
|
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 07/06/2020 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 07/06/2020 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/16/2015 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/29/2013 | SUPPL-2 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/31/2012 | SUPPL-1 | Labeling-Container/Carton Labels, Labeling-Package Insert |
Label is not available on this site. |
ALYACEN 1/35
TABLET;ORAL-28; 0.035MG;1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALYACEN 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 091634 | GLENMARK GENERICS |
| CYCLAFEM 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 076337 | VINTAGE PHARMS LLC |
| DASETTA 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 090948 | NOVAST LABS LTD |
| NORETHINDRONE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 206864 | NAARI PTE LTD |
| NORETHINDRONE AND ETHINYL ESTRADIOL | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 070687 | WATSON LABS TEVA |
| NORINYL 1+35 28-DAY | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 017565 | ALLERGAN |
| NORTREL 1/35-28 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 072696 | BARR |
| NYLIA 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 207056 | AUROBINDO PHARMA LTD |
| PIRMELLA 1/35 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG;1MG | TABLET;ORAL-28 | Prescription | No | AB | 201512 | LUPIN LTD |
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