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 HYDROCHLORIDE از شرکت MYLAN
Abbreviated New Drug Application (ANDA): 075817
Company: MYLAN
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 100MG BASE | TABLET;ORAL | Discontinued |
None |
No | No |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Discontinued |
None |
No | No |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription |
AB |
No | No |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET;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 |
|---|---|---|---|---|---|---|---|
| 06/09/2004 | ORIG-1 | Approval |
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75817.ta.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 08/12/2015 | SUPPL-33 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/02/2015 | SUPPL-32 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 07/02/2015 | SUPPL-30 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/25/2013 | SUPPL-29 | Labeling-Package Insert |
Label is not available on this site. |
||
| 10/25/2013 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/16/2011 | SUPPL-25 | Labeling-Medication Guide, REMS-Modified, Labeling-Package Insert |
Label is not available on this site. |
||
| 05/19/2010 | SUPPL-22 | REMS-Modified, Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 05/10/2010 | SUPPL-19 | Labeling-Container/Carton Labels |
Label is not available on this site. |
||
| 07/22/2009 | SUPPL-17 | Labeling, REMS-Proposal |
Label is not available on this site. |
||
| 08/12/2014 | SUPPL-15 | Labeling |
Label is not available on this site. |
||
| 12/04/2008 | SUPPL-11 | Labeling |
Label is not available on this site. |
||
| 09/16/2008 | SUPPL-9 | Labeling |
Label is not available on this site. |
||
| 06/25/2007 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 06/25/2007 | SUPPL-6 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/05/2006 | SUPPL-4 | Labeling |
Label is not available on this site. |
CIPROFLOXACIN HYDROCHLORIDE
TABLET;ORAL; EQ 500MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIPRO | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019537 | BAYER HLTHCARE |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 077859 | AUROBINDO PHARMA |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 076126 | CARLSBAD |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 076896 | CHARTWELL |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 075593 | DR REDDYS LABS LTD |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 076558 | HIKMA |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 076089 | IVAX SUB TEVA PHARMS |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 075817 | MYLAN |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 076912 | TARO |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 076639 | UNIQUE PHARM LABS |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 076794 | WATSON LABS |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 208921 | YILING |
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