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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 019858
Company: BAYER PHARMS

Products on NDA 019858

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 019858

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.

Labels for NDA 019858

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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