Drugs@FDA: FDA-Approved Drugs

New Drug Application (NDA): 019616
Company: SANOFI AVENTIS US

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
PENETREX	ENOXACIN	200MG	TABLET;ORAL	Discontinued	None	No	No
PENETREX	ENOXACIN	400MG	TABLET;ORAL	Discontinued	None	No	No

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/31/1991	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD		Label is not available on this site.

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/03/2000	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
08/21/2002	SUPPL-6	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19616SLR004,005,006ltr.pdf
08/21/2002	SUPPL-5	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19616SLR004,005,006ltr.pdf
08/21/2002	SUPPL-4	Labeling	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/19616SLR004,005,006ltr.pdf
06/03/1996	SUPPL-3	Labeling		Label is not available on this site.
04/24/1997	SUPPL-2	Labeling		Label is not available on this site.
03/10/1995	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.