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FDA NDA · NDA020635
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
Sponsor: JANSSEN PHARMS
APPLICATION
NDA020635
TYPE
NDA
ORIGINAL APPROVAL
1996-12-20
LATEST ACTION
2017-02-08
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Discontinued
Products
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
LEVOFLOXACIN EQ 750MG/150ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
LEVOFLOXACIN EQ 500MG/100ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
LEVAQUIN · ReferenceDiscontinued
LEVOFLOXACIN EQ 500MG/20ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
LEVAQUIN · ReferenceDiscontinued
LEVOFLOXACIN EQ 750MG/30ML (EQ 25MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER · ReferenceDiscontinued
LEVOFLOXACIN EQ 250MG/50ML (EQ 5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · INJECTABLE · INJECTION
Approval history
2002-11-21Manufacturing (CMC) · Supplement 25 · standardAP
2002-11-06Manufacturing (CMC) · Supplement 24 · standardAP
2002-01-11Manufacturing (CMC) · Supplement 21 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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