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
CYCLAFEM 7/7/7 از شرکت VINTAGE PHARMS LLC
Abbreviated New Drug Application (ANDA): 076338
Company: VINTAGE PHARMS LLC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CYCLAFEM 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,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 |
|---|---|---|---|---|---|---|---|
| 11/16/2010 | 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 |
|---|---|---|---|---|---|
| 07/06/2020 | SUPPL-10 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
||
| 08/26/2016 | SUPPL-9 | Labeling-Patient Package Insert, Labeling-Package Insert |
Label is not available on this site. |
||
| 03/20/2015 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/30/2014 | SUPPL-1 | Labeling-Package Insert, Labeling-Container/Carton Labels |
Label is not available on this site. |
CYCLAFEM 7/7/7
TABLET;ORAL-28; 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ALYACEN 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 091636 | GLENMARK GENERICS |
| CYCLAFEM 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 076338 | VINTAGE PHARMS LLC |
| DASETTA 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 090946 | NOVAST LABS LTD |
| NORTREL 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 075478 | BARR |
| NYLIA 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 207054 | AUROBINDO PHARMA LTD |
| PIRMELLA 7/7/7 | ETHINYL ESTRADIOL; NORETHINDRONE | 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG | TABLET;ORAL-28 | Prescription | No | AB | 201510 | LUPIN LTD |
منبع : www.accessdata.fda.gov
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