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 CHARTWELL
Abbreviated New Drug Application (ANDA): 065384
Company: CHARTWELL
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription |
AB |
No | No |
| CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 08/20/2007 | 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 |
|---|---|---|---|---|---|
| 07/27/2015 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/27/2015 | SUPPL-8 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/27/2015 | SUPPL-7 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/06/2013 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/18/2012 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/06/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 07/16/2008 | SUPPL-2 | Labeling |
Label is not available on this site. |
CLARITHROMYCIN
TABLET;ORAL; 250MG
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 065489 | AUROBINDO |
| CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 065384 | CHARTWELL |
| CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 203584 | HEC PHARM |
| CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 065144 | SANDOZ |
| CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 202710 | STRIDES PHARMA |
| CLARITHROMYCIN | CLARITHROMYCIN | 250MG | TABLET;ORAL | Prescription | No | AB | 065155 | TEVA |
TABLET;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;ORAL | Prescription | No | AB | 065489 | AUROBINDO |
| CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 065384 | CHARTWELL |
| CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 203584 | HEC PHARM |
| CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 065136 | SANDOZ |
| CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 202710 | STRIDES PHARMA |
| CLARITHROMYCIN | CLARITHROMYCIN | 500MG | TABLET;ORAL | Prescription | No | AB | 065155 | TEVA |
منبع : www.accessdata.fda.gov
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