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 ANI PHARMS
Abbreviated New Drug Application (ANDA): 077809
Company: ANI PHARMS
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CIPROFLOXACIN EXTENDED RELEASE | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 425.2MG;EQ 574.9MG BASE | TABLET, EXTENDED RELEASE;ORAL | Discontinued |
None |
No | No |
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 |
---|---|---|---|---|---|---|---|
11/30/2010 | 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 |
---|---|---|---|---|---|
05/06/2019 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
04/24/2019 | SUPPL-7 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
10/18/2018 | SUPPL-6 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
01/27/2017 | SUPPL-5 | Labeling-Medication Guide, Labeling-Patient Package Insert |
Label is not available on this site. |
||
07/26/2016 | SUPPL-4 | Labeling-Package Insert |
Label is not available on this site. |
||
11/19/2013 | SUPPL-3 | Labeling-Package Insert |
Label is not available on this site. |
||
05/01/2012 | SUPPL-2 | REMS-Modified, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/06/2011 | SUPPL-1 | Labeling-Package Insert |
Label is not available on this site. |
منبع : www.accessdata.fda.gov
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