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
ACEBUTOLOL HYDROCHLORIDE از شرکت ANI PHARMS
Abbreviated New Drug Application (ANDA): 074007
Company: ANI PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 200MG BASE | CAPSULE;ORAL | Discontinued |
None |
No | No |
| ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 400MG BASE | CAPSULE;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 |
|---|---|---|---|---|---|---|---|
| 10/18/1995 | 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 |
|---|---|---|---|---|---|
| 11/07/2002 | SUPPL-8 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/25/2002 | SUPPL-7 | Manufacturing (CMC)-Facility |
Label is not available on this site. |
||
| 07/15/2002 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/05/2001 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 03/08/2000 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 11/10/1999 | SUPPL-3 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
||
| 08/05/1998 | SUPPL-2 | Labeling |
Label is not available on this site. |
||
| 06/08/1998 | SUPPL-1 | Manufacturing (CMC) |
Label is not available on this site. |
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