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
BROMOCRIPTINE MESYLATE از شرکت SANDOZ INC
Abbreviated New Drug Application (ANDA): 074631
Company: SANDOZ INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE | EQ 2.5MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 01/13/1998 | 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 |
|---|---|---|---|---|---|
| 01/07/2021 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/18/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 01/28/2002 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 01/28/2002 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 01/28/2002 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 01/28/2002 | SUPPL-2 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 01/28/2002 | SUPPL-1 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
BROMOCRIPTINE MESYLATE
TABLET;ORAL; EQ 2.5MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 077646 | PADAGIS US |
| BROMOCRIPTINE MESYLATE | BROMOCRIPTINE MESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | No | AB | 074631 | SANDOZ INC |
| PARLODEL | BROMOCRIPTINE MESYLATE | EQ 2.5MG BASE | TABLET;ORAL | Prescription | Yes | AB | 017962 | VALIDUS PHARMS |
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