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Last Updated: December 15, 2025

Details for New Drug Application (NDA): 020634

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NDA 020634 describes LEVAQUIN, which is a drug marketed by Janssen Pharms and is included in three NDAs. Additional details are available on the LEVAQUIN profile page.

The generic ingredient in LEVAQUIN is levofloxacin. There are thirty-one drug master file entries for this compound. Forty-three suppliers are listed for this compound. Additional details are available on the levofloxacin profile page.

Summary for 020634

Tradename:	LEVAQUIN
Applicant:	Janssen Pharms
Ingredient:	levofloxacin
Patents:	0

Medical Subject Heading (MeSH) Categories for 020634

Anti-Bacterial Agents
Anti-Infective Agents, Urinary
Cytochrome P-450 CYP1A2 Inhibitors
Topoisomerase II Inhibitors

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 20, 1996	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	500MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Dec 20, 1996	TE:		RLD:	Yes

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	750MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Sep 8, 2000	TE:		RLD:	Yes

Expired US Patents for NDA 020634

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-003	Sep 8, 2000	5,053,407*PED	⤷ Get Started Free
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-001	Dec 20, 1996	4,382,892	⤷ Get Started Free
Janssen Pharms	LEVAQUIN	levofloxacin	TABLET;ORAL	020634-002	Dec 20, 1996	5,053,407*PED	⤷ Get Started Free
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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