Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 076089
Company: IVAX SUB TEVA PHARMS
Company: IVAX SUB TEVA PHARMS
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPROFLOXACIN | CIPROFLOXACIN | 100MG | TABLET; ORAL | None (Tentative Approval) | None | No | No |
| 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 |
|---|---|---|---|---|---|---|---|
| 06/09/2004 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/76089ltr.pdf |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 05/19/2026 | SUPPL-54 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2022 | SUPPL-53 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2022 | SUPPL-52 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/19/2022 | SUPPL-51 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/19/2022 | SUPPL-49 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 12/19/2022 | SUPPL-48 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2022 | SUPPL-46 | Labeling-Package Insert |
Label is not available on this site. |
||
| 04/19/2016 | SUPPL-45 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
| 12/19/2022 | SUPPL-44 | Labeling-Package Insert, Labeling-Medication Guide |
Label is not available on this site. |
||
| 04/24/2013 | SUPPL-42 | Labeling-Package Insert |
Label is not available on this site. |
||
| 03/13/2012 | SUPPL-40 | Labeling-Package Insert |
Label is not available on this site. |
||
| 11/28/2011 | SUPPL-38 | Labeling-Package Insert |
Label is not available on this site. |
||
| 05/08/2011 | SUPPL-37 | Labeling-Package Insert |
Label is not available on this site. |
||
| 09/28/2009 | SUPPL-31 | Labeling |
Label is not available on this site. |
||
| 05/20/2009 | SUPPL-29 | Labeling |
Label is not available on this site. |
||
| 12/02/2008 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 03/16/2008 | SUPPL-27 | Labeling |
Label is not available on this site. |
||
| 02/06/2008 | SUPPL-26 | Labeling |
Label is not available on this site. |
||
| 02/29/2008 | SUPPL-24 | Labeling |
Label is not available on this site. |
||
| 03/10/2008 | SUPPL-22 | Labeling |
Label is not available on this site. |
||
| 10/22/2006 | SUPPL-19 | Labeling |
Label is not available on this site. |
||
| 11/29/2005 | SUPPL-15 | Labeling |
Label is not available on this site. |
CIPROFLOXACIN
There are no Therapeutic Equivalents.
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 |