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 MAYNE PHARMA
Abbreviated New Drug Application (ANDA): 065154
Company: MAYNE PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET, EXTENDED RELEASE;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 |
|---|---|---|---|---|---|---|---|
| 05/18/2005 | 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 |
|---|---|---|---|---|---|
| 12/16/2015 | SUPPL-14 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2015 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2015 | SUPPL-12 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/16/2015 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 12/11/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/19/2012 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/28/2012 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/20/2010 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/22/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 06/30/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 05/10/2006 | SUPPL-1 | 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 |
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