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
CLARITHROMYCIN از شرکت ACTAVIS LABS FL INC
Abbreviated New Drug Application (ANDA): 065145
Company: ACTAVIS LABS FL INC
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 06/24/2004 | 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 |
|---|---|---|---|---|---|
| 03/02/2015 | SUPPL-34 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/02/2015 | SUPPL-33 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/02/2015 | SUPPL-31 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2012 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/07/2011 | SUPPL-25 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/10/2010 | SUPPL-21 | Labeling |
Label is not available on this site. |
||
| 01/30/2008 | SUPPL-10 | Labeling |
Label is not available on this site. |
||
| 05/10/2006 | SUPPL-7 | Labeling |
Label is not available on this site. |
CLARITHROMYCIN
TABLET, EXTENDED RELEASE;ORAL; 500MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 065145 | ACTAVIS LABS FL INC |
| CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 065154 | MAYNE PHARMA |
| CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 208987 | SUNSHINE |
منبع : www.accessdata.fda.gov
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