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
BACLOFEN از شرکت WATSON LABS
Abbreviated New Drug Application (ANDA): 073093
Company: WATSON LABS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| BACLOFEN | BACLOFEN | 20MG | TABLET;ORAL | Discontinued |
None |
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 |
|---|---|---|---|---|---|---|---|
| 01/28/1994 | 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 |
|---|---|---|---|---|---|
| 05/06/2020 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/12/2001 | SUPPL-13 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 03/21/2000 | SUPPL-11 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/08/1997 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/07/1997 | SUPPL-8 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/28/1997 | SUPPL-7 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1996 | SUPPL-5 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 12/31/1996 | SUPPL-4 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 04/24/1997 | SUPPL-3 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/17/1996 | SUPPL-2 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 10/13/1994 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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