Drugs@FDA: FDA-Approved Drugs
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPRO | CIPROFLOXACIN HYDROCHLORIDE | EQ 250MG BASE | TABLET;ORAL | Prescription | AB | Yes | No |
| CIPRO | CIPROFLOXACIN HYDROCHLORIDE | EQ 500MG BASE | TABLET;ORAL | Prescription | AB | Yes | Yes |
| CIPRO | CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 |
|---|---|---|---|---|---|---|---|
| 10/22/1987 | ORIG-1 | Approval | Type 1 - New Molecular Entity | PRIORITY |
Label is not available on this site. |
Supplements
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
|---|---|---|---|---|---|
| 03/30/2021 | SUPPL-93 | Labeling-Package Insert |
Label is not available on this site. |
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| 11/11/2021 | SUPPL-92 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/08/2020 | SUPPL-91 | Labeling-Package Insert |
Label is not available on this site. |
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| 03/05/2020 | SUPPL-90 | Labeling-Package Insert |
Label is not available on this site. |
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| 05/03/2019 | SUPPL-89 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/18/2018 | SUPPL-88 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/26/2017 | SUPPL-87 | Labeling-Package Insert |
Label is not available on this site. |
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| 07/26/2016 | SUPPL-86 | Labeling-Package Insert |
Label is not available on this site. |
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| 09/14/2016 | SUPPL-85 | Labeling-Package Insert |
Label is not available on this site. |
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| 02/02/2015 | SUPPL-83 | Efficacy-New Indication |
Label is not available on this site. |
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| 08/14/2013 | SUPPL-82 | Labeling-Package Insert |
Label is not available on this site. |
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| 01/30/2013 | SUPPL-81 | Labeling-Package Insert |
Label is not available on this site. |
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| 10/18/2011 | SUPPL-80 | Labeling-Package Insert |
Label is not available on this site. |
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| 08/03/2011 | SUPPL-79 | REMS-Modified |
Label is not available on this site. |
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| 06/10/2011 | SUPPL-78 | Labeling |
Label is not available on this site. |
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| 02/25/2011 | SUPPL-75 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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| 11/15/2011 | SUPPL-74 | Labeling |
Label is not available on this site. |
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| 04/06/2009 | SUPPL-73 | Labeling |
Label is not available on this site. |
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| 06/24/2009 | SUPPL-71 | Labeling |
Label is not available on this site. |
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| 04/27/2009 | SUPPL-70 | Labeling, REMS-Proposal |
Label is not available on this site. |
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| 02/13/2009 | SUPPL-69 | Labeling |
Label is not available on this site. |
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| 10/03/2008 | SUPPL-68 | Labeling |
Label is not available on this site. |
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| 01/18/2008 | SUPPL-67 | Labeling |
Label is not available on this site. |
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| 06/25/2007 | SUPPL-65 | Labeling |
Label is not available on this site. |
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| 06/19/2006 | SUPPL-62 | Labeling |
Label is not available on this site. |
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| 11/09/2005 | SUPPL-60 | Labeling |
Label is not available on this site. |
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| 05/18/2005 | SUPPL-57 | Labeling |
Label is not available on this site. |
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| 07/14/2004 | SUPPL-54 | Labeling |
Label is not available on this site. |
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| 07/14/2004 | SUPPL-53 | Labeling |
Label is not available on this site. |
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| 01/07/2005 | SUPPL-52 | Efficacy-Accelerated Approval |
Label is not available on this site. |
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| 03/15/2004 | SUPPL-51 | Labeling |
Label is not available on this site. |
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| 03/15/2004 | SUPPL-50 | Labeling |
Label is not available on this site. |
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| 03/25/2004 | SUPPL-49 | Efficacy-New Patient Population |
Label is not available on this site. |
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| 03/15/2004 | SUPPL-48 | Labeling |
Label is not available on this site. |
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| 04/17/2002 | SUPPL-41 | Labeling |
Label is not available on this site. |
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| 06/28/2000 | SUPPL-40 | Labeling |
Label is not available on this site. |
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| 06/28/2000 | SUPPL-39 | Labeling |
Label is not available on this site. |
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| 08/30/2000 | SUPPL-38 | Efficacy-New Indication |
Label is not available on this site. |
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| 06/28/2000 | SUPPL-36 | Labeling |
Label is not available on this site. |
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| 06/28/2000 | SUPPL-34 | Labeling |
Label is not available on this site. |
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| 09/17/1998 | SUPPL-33 | Labeling |
Label is not available on this site. |
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| 09/17/1998 | SUPPL-31 | Labeling |
Label is not available on this site. |
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| 09/17/1998 | SUPPL-30 | Labeling |
Label is not available on this site. |
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| 06/03/1997 | SUPPL-29 | Efficacy-New Indication |
Label is not available on this site. |
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| 11/22/1996 | SUPPL-28 | Labeling |
Label is not available on this site. |
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| 04/03/1998 | SUPPL-27 | Efficacy-New Patient Population |
Label is not available on this site. |
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| 09/26/1997 | SUPPL-25 | Labeling |
Label is not available on this site. |
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| 10/10/1996 | SUPPL-22 | Efficacy-New Indication |
Label is not available on this site. |
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| 09/11/1996 | SUPPL-21 | Efficacy-New Indication |
Label is not available on this site. |
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| 09/13/1995 | SUPPL-19 | Efficacy-New Indication |
Label is not available on this site. |
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| 05/15/1997 | SUPPL-16 | Efficacy-New Indication |
Label is not available on this site. |
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| 07/21/1994 | SUPPL-15 | Efficacy-New Indication |
Label is not available on this site. |
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| 07/21/1994 | SUPPL-13 | Efficacy-New Indication |
Label is not available on this site. |
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| 01/22/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
CIPRO
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 | 075939 | AMNEAL |
| 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 | 075939 | AMNEAL |
| 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 |