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 AMNEAL PHARM
Abbreviated New Drug Application (ANDA): 075047
Company: AMNEAL PHARM
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 200MG BASE | CAPSULE;ORAL | Prescription |
AB |
No | Yes |
| ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 400MG BASE | CAPSULE;ORAL | Prescription |
AB |
No | Yes |
Original Approvals or Tentative Approvals
| Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
|---|---|---|---|---|---|---|---|
| 12/30/1999 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75047ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 01/21/2011 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 04/06/2015 | SUPPL-7 | Labeling |
Label is not available on this site. |
||
| 05/22/2007 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/22/2007 | SUPPL-4 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
||
| 05/22/2007 | SUPPL-3 | Manufacturing (CMC)-Manufacturing Process |
Label is not available on this site. |
ACEBUTOLOL HYDROCHLORIDE
CAPSULE;ORAL; EQ 200MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075047 | AMNEAL PHARM |
| ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 200MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074288 | MYLAN |
CAPSULE;ORAL; EQ 400MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 400MG BASE | CAPSULE;ORAL | Prescription | No | AB | 075047 | AMNEAL PHARM |
| ACEBUTOLOL HYDROCHLORIDE | ACEBUTOLOL HYDROCHLORIDE | EQ 400MG BASE | CAPSULE;ORAL | Prescription | No | AB | 074288 | MYLAN |
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