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 ANCHEN PHARMS
Abbreviated New Drug Application (ANDA): 078166
Company: ANCHEN 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 | Prescription |
AB |
No | Yes |
| CIPROFLOXACIN EXTENDED RELEASE | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 212.6MG;EQ 287.5MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription |
None |
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 |
|---|---|---|---|---|---|---|---|
| 11/27/2007 | 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-14 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 10/18/2018 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/26/2019 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/26/2016 | SUPPL-11 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/18/2016 | SUPPL-10 | Labeling-Package Insert |
Label is not available on this site. |
||
| 07/18/2016 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/14/2013 | SUPPL-8 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 11/14/2012 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/17/2010 | SUPPL-2 | Labeling-Container/Carton Labels, REMS-Proposal |
Label is not available on this site. |
||
| 06/19/2009 | SUPPL-1 | Labeling |
Label is not available on this site. |
CIPROFLOXACIN EXTENDED RELEASE
TABLET, EXTENDED RELEASE;ORAL; 425.2MG;EQ 574.9MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN EXTENDED RELEASE | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 425.2MG;EQ 574.9MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 078166 | ANCHEN PHARMS |
| CIPROFLOXACIN EXTENDED RELEASE | CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE | 425.2MG;EQ 574.9MG BASE | TABLET, EXTENDED RELEASE;ORAL | Prescription | No | AB | 077701 | DR REDDYS LABS LTD |
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