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
CAMILA از شرکت MAYNE PHARMA
Abbreviated New Drug Application (ANDA): 076177
Company: MAYNE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CAMILA | NORETHINDRONE | 0.35MG | 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 |
|---|---|---|---|---|---|---|---|
| 10/21/2002 | 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 |
|---|---|---|---|---|---|
| 06/10/2011 | SUPPL-6 | Labeling-Package Insert, Labeling-Patient Package Insert |
Label is not available on this site. |
CAMILA
TABLET;ORAL-28; 0.35MG
TE Code = AB1
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CAMILA | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 076177 | MAYNE PHARMA |
| HEATHER | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 090454 | GLENMARK GENERICS |
| INCASSIA | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 207304 | AUROBINDO PHARMA LTD |
| NOR-QD | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | Yes | AB1 | 017060 | TEVA BRANDED PHARM |
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 202260 | AMNEAL PHARMS |
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 091325 | LUPIN LTD |
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 201483 | MYLAN LABS LTD |
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 206807 | NAARI PTE LTD |
| NORETHINDRONE | NORETHINDRONE | 0.35MG | TABLET;ORAL-28 | Prescription | No | AB1 | 202014 | NOVAST LABS |
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