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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020013
Company: PHARMACIA

Products on NDA 020013

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020013

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.

Labels for NDA 020013

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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