Details for New Drug Application (NDA): 019616

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NDA 019616 describes PENETREX, which is a drug marketed by Sanofi Aventis Us and is included in one NDA. Additional details are available on the PENETREX profile page.

The generic ingredient in PENETREX is enoxacin. There are three drug master file entries for this compound. Additional details are available on the enoxacin profile page.

Summary for 019616

Tradename:	PENETREX
Applicant:	Sanofi Aventis Us
Ingredient:	enoxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 019616

Anti-Bacterial Agents
Cytochrome P-450 CYP1A2 Inhibitors
Topoisomerase II Inhibitors

Profile for product number 004

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	200MG
Approval Date:	Dec 31, 1991	TE:		RLD:	No

Profile for product number 005

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Dec 31, 1991	TE:		RLD:	No

Expired US Patents for NDA 019616

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-005	Dec 31, 1991	4,359,578	⤷ Subscribe
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-004	Dec 31, 1991	4,352,803	⤷ Subscribe
Sanofi Aventis Us	PENETREX	enoxacin	TABLET;ORAL	019616-005	Dec 31, 1991	4,442,101	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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