Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 077859
Company: AUROBINDO PHARMA
Company: AUROBINDO PHARMA
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | AB | No | No |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | 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 |
|---|---|---|---|---|---|---|---|
| 04/26/2007 | 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 |
|---|---|---|---|---|---|
| 03/27/2025 | SUPPL-46 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 02/09/2024 | SUPPL-44 | Labeling-Package Insert, Labeling-Container/Carton Labels, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/29/2024 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2024 | SUPPL-35 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2024 | SUPPL-32 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 08/29/2024 | SUPPL-30 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 08/29/2024 | SUPPL-29 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
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| 08/29/2024 | SUPPL-27 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/29/2024 | SUPPL-26 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/29/2024 | SUPPL-25 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 10/06/2015 | SUPPL-24 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/06/2015 | SUPPL-18 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/24/2013 | SUPPL-17 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/01/2014 | SUPPL-15 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/28/2012 | SUPPL-13 | Labeling-Package Insert |
Label is not available on this site. |
||
| 02/27/2012 | SUPPL-12 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/08/2011 | SUPPL-11 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 05/08/2011 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
||
| 08/24/2009 | SUPPL-7 | Labeling, REMS-Proposal |
Label is not available on this site. |
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| 02/23/2011 | SUPPL-6 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/20/2009 | SUPPL-5 | Labeling |
Label is not available on this site. |
||
| 12/02/2008 | SUPPL-4 | Labeling |
Label is not available on this site. |
||
| 05/13/2008 | SUPPL-3 | Labeling |
Label is not available on this site. |
||
| 10/05/2007 | SUPPL-1 | Labeling |
Label is not available on this site. |
CIPROFLOXACIN HYDROCHLORIDE
TABLET;ORAL; EQ 250MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIPRO | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | Yes | AB | 019537 | BAYER HLTHCARE |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 076593 | AIPING PHARM INC |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 077859 | AUROBINDO PHARMA |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 076126 | CARLSBAD |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 076896 | CHARTWELL |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 075593 | DR REDDYS LABS LTD |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 076558 | HIKMA |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 076089 | IVAX SUB TEVA PHARMS |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 076639 | UNIQUE |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 076794 | WATSON LABS |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | No | AB | 208921 | YILING |
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 | 076593 | AIPING PHARM INC |
| 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 | RISING |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | No | AB | 076639 | UNIQUE |
| 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 |
TABLET;ORAL; EQ 750MG BASE
TE Code = AB
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
|---|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET;ORAL | Prescription | No | AB | 076593 | AIPING PHARM INC |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET;ORAL | Prescription | No | AB | 077859 | AUROBINDO PHARMA |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET;ORAL | Prescription | No | AB | 076126 | CARLSBAD |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET;ORAL | Prescription | No | AB | 076896 | CHARTWELL |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET;ORAL | Prescription | No | AB | 075593 | DR REDDYS LABS LTD |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET;ORAL | Prescription | No | AB | 076558 | HIKMA |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET;ORAL | Prescription | No | AB | 076089 | IVAX SUB TEVA PHARMS |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET;ORAL | Prescription | No | AB | 076639 | UNIQUE |
| CIPROFLOXACIN HYDROCHLORIDE | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE | TABLET;ORAL | Prescription | No | AB | 076794 | WATSON LABS |