Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 019537
Company: BAYER HLTHCARE
Company: BAYER HLTHCARE
| Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
|---|---|---|---|---|---|---|---|
| CIPRO | CIPROFLOXACIN HYDROCHLORIDE | EQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |
| 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| CIPROFLOXACIN HYDROCHLORIDE | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET;ORAL | Discontinued | None | Yes | No |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 (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019537s093,020780s049lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019537Orig1s093,020780Orig1s049ltr.pdf | |
| 11/11/2021 | SUPPL-92 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019537s092lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/019537Orig1s092ltr.pdf | |
| 05/08/2020 | SUPPL-91 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019537s091,020780s048lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019537Orig1s091, 020780Orig1s048ltr.pdf | |
| 03/05/2020 | SUPPL-90 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019537s090,020780s047lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/019537Orig1s090, 020780Orig1s047ltr.pdf | |
| 05/03/2019 | SUPPL-89 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019537s089,020780s046lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019537Orig1s089, 020780Orig1s046ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/019537Orig1s089, 020780Orig1s046ltr.pdf | |
| 10/18/2018 | SUPPL-88 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019537s088,020780s045lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/019537Orig1s088,020780Orig1s045ltr.pdf | |
| 07/26/2017 | SUPPL-87 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019537s087,020780s044lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/019537Orig1s087,020780Orig1s044ltr.pdf |
| 07/26/2016 | SUPPL-86 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s086lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537s086,019847s057,019857s065,020780s043,021473Orig1s037ltr.pdf | |
| 09/14/2016 | SUPPL-85 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s085,020780s042lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/019537Orig1s085,020780Orig1s042ltr.pdf | |
| 11/21/2014 | SUPPL-84 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 02/02/2015 | SUPPL-83 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019537s083,020780s041lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/019537Orig1s083,019847Orig1s055,019857Orig1s063,020780Orig1s041ltr.pdf | |
| 08/14/2013 | SUPPL-82 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s082,020780s040lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019537Orig1s082,020780Orig1s040ltr.pdf | |
| 01/30/2013 | SUPPL-81 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s081,020780s039lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/019537Orig1s081,020780Orig1s039ltr.pdf | |
| 10/18/2011 | SUPPL-80 | Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s080,019847s052,019857s059,020780s038,021473s033ltr.pdf | |
| 08/03/2011 | SUPPL-79 | REMS-Modified |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s079,019847s051,019857s058,020780s037,021473s032ltr.pdf |
| 06/10/2011 | SUPPL-78 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s078,020780s036lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s078,020780s036ltr.pdf | |
| 02/25/2011 | SUPPL-75 | Labeling-Medication Guide, Labeling-Package Insert |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s075,020780s033lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s075,019847s047,019857s054,020780s033,021473s028ltr.pdf | |
| 11/15/2011 | SUPPL-74 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s074,020780s032lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019537s074,020780s032ltr.pdf | |
| 04/06/2009 | SUPPL-73 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s073,020780s030lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s073,020780s030ltr.pdf | |
| 06/24/2009 | SUPPL-71 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s071,019847s045,019857s052,020780s029,021473s026ltr.pdf |
| 04/27/2009 | SUPPL-70 | Labeling, REMS-Proposal |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s070,019847s044ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/019537Orig1s070.pdf | |
| 02/13/2009 | SUPPL-69 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019537s069,019847s043,019857s050,020780s027ltr.pdf | |
| 10/03/2008 | SUPPL-68 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019537s068,019847s042ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2008/019537Orig1s068.pdf | |
| 01/18/2008 | SUPPL-67 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s067,020780s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019537s067,020780s025ltr.pdf | |
| 06/25/2007 | SUPPL-65 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019537s65lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019537s65,19847s39,19857s46,20780s24,21473s22ltr.pdf | |
| 06/19/2006 | SUPPL-62 | Labeling |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019537s62,020780s23,019847s37,019857s42,021473s16LTR.pdf |
| 11/09/2005 | SUPPL-60 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s60,019847s36,019857s41,020780s20,021473s13ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/019537_S060_Cipro Tablets.pdf | |
| 05/18/2005 | SUPPL-57 | Labeling |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s057,020780s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019537s057,020780s019ltr.pdf | |
| 07/14/2004 | SUPPL-54 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s053,054,20780s017,018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S054_CIPRO.pdf | |
| 07/14/2004 | SUPPL-53 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s053,054,20780s017,018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S053_CIPRO.pdf | |
| 01/07/2005 | SUPPL-52 | Efficacy-Accelerated Approval |
Label (PDF)
Letter (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/19537s052,19847s030,19857s035,20780s016ltr.pdf | |
| 03/15/2004 | SUPPL-51 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S051_CIPRO.pdf | |
| 03/15/2004 | SUPPL-50 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S050_CIPRO.pdf | |
| 03/25/2004 | SUPPL-49 | Efficacy-New Patient Population |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537s049,19857s031,19847s027,20780s013ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537s49_19847s27_19857s31_20780s13TOC.cfm | |
| 03/15/2004 | SUPPL-48 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/19537slr048,050,051,20780slr012,014,015ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/019537_S048_CIPRO.pdf | |
| 12/10/2002 | SUPPL-45 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019537_S045_CIPRO.pdf |
| 08/02/2002 | SUPPL-44 | Manufacturing (CMC)-Expiration Date |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019537_S044_CIPRO.pdf |
| 12/13/2002 | SUPPL-43 | Manufacturing (CMC)-Packaging |
Letter (PDF)
Review (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19537scp043ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019537_S043_CIPPRO.pdf |
| 12/04/2001 | SUPPL-42 | Manufacturing (CMC) |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/019537_S042_Cipro Tablets.pdf |
| 04/17/2002 | SUPPL-41 | Labeling |
Label (PDF)
Letter (PDF) Review (PDF) |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19537s41lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19537s41ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019537_S041_CIPRO.pdf | |
| 06/28/2000 | SUPPL-40 | Labeling |
Label is not available on this site. |
||
| 06/28/2000 | SUPPL-39 | Labeling |
Label is not available on this site. |
||
| 08/30/2000 | SUPPL-38 | Efficacy-New Indication |
Label (PDF)
Letter (PDF) Review |
https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20780S08ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-537S038_Cipro.cfm | |
| 06/28/2000 | SUPPL-36 | Labeling |
Label is not available on this site. |
||
| 06/09/1999 | SUPPL-35 | Manufacturing (CMC)-Control |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/019537_S035_Cipro Tablets.pdf |
| 06/28/2000 | SUPPL-34 | Labeling |
Label is not available on this site. |
||
| 09/17/1998 | SUPPL-33 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019537_S033_CIPRO.pdf |
| 11/18/1998 | SUPPL-32 | Manufacturing (CMC)-Packaging |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/1998/019537_S032_Cipro Tablets.pdf |
| 09/17/1998 | SUPPL-31 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019537_S031_CIPRO.pdf |
| 09/17/1998 | SUPPL-30 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/019537_S030_CIPRO.pdf |
| 06/03/1997 | SUPPL-29 | Efficacy-New Indication |
Label is not available on this site. |
||
| 11/22/1996 | SUPPL-28 | Labeling |
Label is not available on this site. |
||
| 04/03/1998 | SUPPL-27 | Efficacy-New Patient Population |
Label is not available on this site. |
||
| 04/08/1996 | SUPPL-26 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/26/1997 | SUPPL-25 | Labeling |
Review (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019537_S025_CIPRO.pdf |
| 10/10/1996 | SUPPL-22 | Efficacy-New Indication |
Label is not available on this site. |
||
| 09/11/1996 | SUPPL-21 | Efficacy-New Indication |
Label is not available on this site. |
||
| 03/14/1994 | SUPPL-20 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 09/13/1995 | SUPPL-19 | Efficacy-New Indication |
Label is not available on this site. |
||
| 10/18/2011 | SUPPL-18 | Labeling |
Label is not available on this site. |
||
| 09/10/1992 | SUPPL-17 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 05/15/1997 | SUPPL-16 | Efficacy-New Indication |
Label is not available on this site. |
||
| 07/21/1994 | SUPPL-15 | Efficacy-New Indication |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-537s015_Cipro.cfm |
| 07/21/1994 | SUPPL-13 | Efficacy-New Indication |
Review
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/19-537s015_Cipro.cfm |
| 11/19/1991 | SUPPL-9 | Manufacturing (CMC) |
Label is not available on this site. |
||
| 01/22/1993 | SUPPL-8 | Labeling |
Label is not available on this site. |
||
| 10/25/1989 | SUPPL-7 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 11/01/1988 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 10/12/1988 | SUPPL-4 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/24/1988 | SUPPL-2 | Manufacturing (CMC)-Control |
Label is not available on this site. |
||
| 02/24/1988 | SUPPL-1 | Manufacturing (CMC)-Expiration Date |
Label is not available on this site. |
| Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert |
Note | Url |
|---|---|---|---|---|---|
| 11/11/2021 | SUPPL-92 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019537s092lbl.pdf | |
| 03/30/2021 | SUPPL-93 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/019537s093,020780s049lbl.pdf | |
| 05/08/2020 | SUPPL-91 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019537s091,020780s048lbl.pdf | |
| 03/05/2020 | SUPPL-90 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/019537s090,020780s047lbl.pdf | |
| 05/03/2019 | SUPPL-89 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/019537s089,020780s046lbl.pdf | |
| 10/18/2018 | SUPPL-88 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/019537s088,020780s045lbl.pdf | |
| 07/26/2017 | SUPPL-87 | Labeling-Package Insert | Label (PDF) | Please see www.fda.gov/STIC for labeling requirements on susceptibility test interpretive criteria for systemic antibacterial and antifungal drugs. | https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/019537s087,020780s044lbl.pdf |
| 09/14/2016 | SUPPL-85 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s085,020780s042lbl.pdf | |
| 07/26/2016 | SUPPL-86 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/019537s086lbl.pdf | |
| 02/02/2015 | SUPPL-83 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/019537s083,020780s041lbl.pdf | |
| 08/14/2013 | SUPPL-82 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s082,020780s040lbl.pdf | |
| 01/30/2013 | SUPPL-81 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2013/019537s081,020780s039lbl.pdf | |
| 11/15/2011 | SUPPL-74 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s074,020780s032lbl.pdf | |
| 10/18/2011 | SUPPL-80 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s080,019847s052,019857s059,020780s038,021473s033lbl.pdf | |
| 06/10/2011 | SUPPL-78 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s078,020780s036lbl.pdf | |
| 02/25/2011 | SUPPL-75 | Labeling-Medication Guide | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s075,020780s033lbl.pdf | |
| 02/25/2011 | SUPPL-75 | Labeling-Package Insert | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/019537s075,020780s033lbl.pdf | |
| 04/27/2009 | SUPPL-70 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf | |
| 04/27/2009 | SUPPL-70 | REMS-Proposal | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s701984744198575120780282147325L.pdf | |
| 04/06/2009 | SUPPL-73 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s073,020780s030lbl.pdf | |
| 02/13/2009 | SUPPL-69 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019537s69,19847s43,19857s50,20780s27lbl.pdf | |
| 10/03/2008 | SUPPL-68 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s68,19847s42,19857s49,20780s26,21473s24lbl.pdf | |
| 01/18/2008 | SUPPL-67 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019537s067,020780s025lbl.pdf | |
| 06/25/2007 | SUPPL-65 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019537s65lbl.pdf | |
| 11/09/2005 | SUPPL-60 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s60,019847s36,019857s41,020780s20,021473s13lbl.pdf | |
| 05/18/2005 | SUPPL-57 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019537s057,020780s019lbl.pdf | |
| 01/07/2005 | SUPPL-52 | Efficacy-Accelerated Approval | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/19537s052,19847s030,19857s035,20780s016lbl.pdf | |
| 07/14/2004 | SUPPL-54 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf | |
| 07/14/2004 | SUPPL-53 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s053,054,20780s017,018lbl.pdf | |
| 03/25/2004 | SUPPL-49 | Efficacy-New Patient Population | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537s049,19857s031,19847se5-027,20780se5-013_cipro_lbl.pdf | |
| 03/15/2004 | SUPPL-51 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf | |
| 03/15/2004 | SUPPL-50 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf | |
| 03/15/2004 | SUPPL-48 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19537slr048,050,051,20780slr012,014,015_cipro_lbl.pdf | |
| 04/17/2002 | SUPPL-41 | Labeling | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19537s41lbl.pdf | |
| 08/30/2000 | SUPPL-38 | Efficacy-New Indication | Label (PDF) | https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf |
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 | 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 | 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 |