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
CABERGOLINE از شرکت IVAX SUB TEVA PHARMS
Abbreviated New Drug Application (ANDA): 077750
Company: IVAX SUB TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CABERGOLINE | CABERGOLINE | 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 |
|---|---|---|---|---|---|---|---|
| 03/07/2007 | 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 |
|---|---|---|---|---|---|
| 12/13/2019 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/26/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/26/2011 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/12/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 10/01/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |
CABERGOLINE
TABLET;ORAL; 0.5MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CABERGOLINE | CABERGOLINE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 204735 | INGENUS PHARMS LLC |
| CABERGOLINE | CABERGOLINE | 0.5MG | TABLET;ORAL | Prescription | No | AB | 077750 | IVAX SUB TEVA PHARMS |
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