Drugs@FDA: FDA-Approved Drugs
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. |
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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. |
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08/09/1996 | SUPPL-14 | Labeling |
Label is not available on this site. |
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07/09/1996 | SUPPL-13 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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04/03/1998 | SUPPL-12 | Efficacy-New Patient Population |
Label is not available on this site. |
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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. |
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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. |
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04/23/1992 | SUPPL-5 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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05/13/1992 | SUPPL-3 | Manufacturing (CMC)-Control |
Label is not available on this site. |
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04/24/1991 | SUPPL-2 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
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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 |