Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020013
Company: PHARMACIA
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
MAXAQUIN LOMEFLOXACIN HYDROCHLORIDE EQ 400MG BASE TABLET;ORAL 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
02/21/1992 ORIG-1 Approval Type 1 - New Molecular Entity 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
03/16/2005 SUPPL-15 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20013s015lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20013s015ltr.pdf
03/06/2004 SUPPL-14 Labeling Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20013slr014_mazaquin_lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20013slr014ltr.pdf
05/06/1999 SUPPL-13 Labeling

Label is not available on this site.

05/06/1999 SUPPL-12 Labeling

Label is not available on this site.

05/06/1999 SUPPL-11 Labeling

Label is not available on this site.

09/11/1996 SUPPL-10 Labeling

Label is not available on this site.

02/20/1997 SUPPL-9 Labeling

Label is not available on this site.

10/24/2001 SUPPL-8 Labeling Label (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20013s8lbl.pdf
10/09/1996 SUPPL-7 Efficacy-New Indication

Label is not available on this site.

09/27/1996 SUPPL-6 Labeling

Label is not available on this site.

09/20/1993 SUPPL-3 Manufacturing (CMC)-Packaging

Label is not available on this site.

07/21/1993 SUPPL-2 Labeling

Label is not available on this site.

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
03/16/2005 SUPPL-15 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2005/20013s015lbl.pdf
03/06/2004 SUPPL-14 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20013slr014_mazaquin_lbl.pdf
10/24/2001 SUPPL-8 Labeling Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20013s8lbl.pdf

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