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
CIPROFLOXACIN EXTENDED RELEASE از شرکت FOSUN PHARMA
Abbreviated New Drug Application (ANDA): 078712
Company: FOSUN PHARMA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CIPROFLOXACIN EXTENDED RELEASE | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 212.6MG;EQ 287.5MG BASE | TABLET, EXTENDED RELEASE;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 |
---|---|---|---|---|---|---|---|
12/11/2007 | 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 |
---|---|---|---|---|---|
05/03/2019 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
10/18/2018 | SUPPL-5 | Labeling-Package Insert |
Label is not available on this site. |
||
04/24/2019 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
07/26/2016 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
07/26/2016 | SUPPL-2 | Labeling-Package Insert |
Label is not available on this site. |
||
12/04/2013 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
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