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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020677
Company: MYLAN

Products on NDA 020677

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ZAGAM	SPARFLOXACIN	200MG	TABLET;ORAL	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020677

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/19/1996	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/pre96/020677Orig1s000rev.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2003	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020677s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20677slr006ltr.pdf
05/11/2001	SUPPL-5	Manufacturing (CMC)		Label is not available on this site.
10/02/2002	SUPPL-4	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20677s4lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20677slr004ltr.pdf
12/10/1999	SUPPL-3	Manufacturing (CMC)	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-677s003_Zagam.cfm
10/19/1999	SUPPL-2	Labeling	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-677s001s002_Zagam.cfm
10/19/1999	SUPPL-1	Labeling	Review	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20-677s001s002_Zagam.cfm

Labels for NDA 020677

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/04/2003	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020677s006lbl.pdf
10/02/2002	SUPPL-4	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20677s4lbl.pdf

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