Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 019858
Company: BAYER PHARMS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER CIPROFLOXACIN 200MG/100ML INJECTABLE;INJECTION 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
12/26/1990 ORIG-1 Approval Type 3 - New Dosage Form STANDARD

Label is not available on this site.

Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
04/17/2002 SUPPL-22 Labeling Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19847s26ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/019858_S022_CIPRO.pdf
08/30/2000 SUPPL-21 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-20 Labeling

Label is not available on this site.

09/24/1998 SUPPL-19 Labeling

Label is not available on this site.

09/24/1998 SUPPL-18 Efficacy-New Indication

Label is not available on this site.

09/24/1998 SUPPL-17 Labeling

Label is not available on this site.

09/24/1998 SUPPL-16 Efficacy-New Indication

Label is not available on this site.

08/07/1997 SUPPL-15 Efficacy-New Indication

Label is not available on this site.

08/09/1996 SUPPL-14 Labeling

Label is not available on this site.

07/09/1996 SUPPL-13 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/03/1998 SUPPL-12 Efficacy-New Patient Population

Label is not available on this site.

09/26/1997 SUPPL-11 Labeling Review (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/019858_S011_CIPRO.pdf
10/10/1996 SUPPL-9 Efficacy-New Indication

Label is not available on this site.

10/21/1996 SUPPL-8 Efficacy-New Indication

Label is not available on this site.

10/25/1995 SUPPL-6 Labeling

Label is not available on this site.

04/23/1992 SUPPL-5 Manufacturing (CMC)-Control

Label is not available on this site.

05/13/1992 SUPPL-3 Manufacturing (CMC)-Control

Label is not available on this site.

04/24/1991 SUPPL-2 Manufacturing (CMC)-Packaging

Label is not available on this site.

04/24/1991 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
04/17/2002 SUPPL-22 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19847s26lbl.pdf
08/30/2000 SUPPL-21 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20780S08lbl.pdf

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