Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020087
Company: ORTHO MCNEIL PHARM
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
FLOXIN OFLOXACIN 20MG/ML INJECTABLE;INJECTION Discontinued None No No
FLOXIN OFLOXACIN 40MG/ML INJECTABLE;INJECTION Discontinued None No No
FLOXIN IN DEXTROSE 5% OFLOXACIN 400MG/100ML INJECTABLE;INJECTION Discontinued None No No
FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER OFLOXACIN 4MG/ML INJECTABLE;INJECTION Discontinued None No No
FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER OFLOXACIN 400MG/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
03/31/1992 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
12/08/1999 SUPPL-24 Labeling

Label is not available on this site.

12/08/1999 SUPPL-23 Labeling

Label is not available on this site.

03/25/1999 SUPPL-22 Manufacturing (CMC)

Label is not available on this site.

12/08/1999 SUPPL-21 Labeling

Label is not available on this site.

10/20/1998 SUPPL-20 Manufacturing (CMC)-Control

Label is not available on this site.

05/12/1998 SUPPL-19 Manufacturing (CMC)

Label is not available on this site.

04/16/1997 SUPPL-18 Manufacturing (CMC)

Label is not available on this site.

12/19/1996 SUPPL-17 Efficacy-New Indication

Label is not available on this site.

08/11/1997 SUPPL-16 Labeling

Label is not available on this site.

09/11/1996 SUPPL-15 Labeling

Label is not available on this site.

03/22/1994 SUPPL-13 Manufacturing (CMC)-Control

Label is not available on this site.

12/27/1993 SUPPL-12 Manufacturing (CMC)-Control

Label is not available on this site.

12/07/1993 SUPPL-11 Manufacturing (CMC)-Expiration Date

Label is not available on this site.

05/10/1993 SUPPL-2 Manufacturing (CMC)

Label is not available on this site.

05/19/1992 SUPPL-1 Manufacturing (CMC)-Packaging

Label is not available on this site.

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