Friday, September 16, 2016

Levaquin


Levaquin is a brand name of levofloxacin, approved by the FDA in the following formulation(s):


LEVAQUIN (levofloxacin - injectable; injection)



  • Manufacturer: JANSSEN PHARMS

    Approval date: December 20, 1996

    Strength(s): EQ 500MG/20ML (EQ 25MG/ML) [RLD][AP], EQ 750MG/30ML (EQ 25MG/ML) [RLD][AP]

LEVAQUIN (levofloxacin - solution; oral)



  • Manufacturer: JANSSEN PHARMS

    Approval date: October 21, 2004

    Strength(s): 250MG/10ML [RLD][AA]

LEVAQUIN (levofloxacin - tablet; oral)



  • Manufacturer: JANSSEN PHARMS

    Approval date: December 20, 1996

    Strength(s): 250MG [AB], 500MG [AB]


  • Manufacturer: JANSSEN PHARMS

    Approval date: September 8, 2000

    Strength(s): 750MG [RLD][AB]

Has a generic version of Levaquin been approved?


A generic version of Levaquin has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Levaquin and have been approved by the FDA:


levofloxacin injectable; injection



  • Manufacturer: AKORN

    Approval date: June 20, 2011

    Strength(s): EQ 500MG/20ML (EQ 25MG/ML) [AP], EQ 750MG/30ML (EQ 25MG/ML) [AP]


  • Manufacturer: SAGENT PHARMS

    Approval date: June 20, 2011

    Strength(s): EQ 500MG/20ML (EQ 25MG/ML) [AP], EQ 750MG/30ML (EQ 25MG/ML) [AP]

levofloxacin solution; oral



  • Manufacturer: HI TECH PHARMA

    Approval date: June 20, 2011

    Strength(s): 250MG/10ML [AA]

levofloxacin tablet; oral



  • Manufacturer: APOTEX INC

    Approval date: September 29, 2011

    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]


  • Manufacturer: AUROBINDO PHARMA LTD

    Approval date: June 20, 2011

    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]


  • Manufacturer: DR REDDYS LABS INC

    Approval date: June 20, 2011

    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]


  • Manufacturer: GLENMARK GENERICS

    Approval date: June 20, 2011

    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]


  • Manufacturer: LUPIN

    Approval date: June 20, 2011

    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]


  • Manufacturer: MYLAN

    Approval date: June 20, 2011

    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]


  • Manufacturer: ORCHID HLTHCARE

    Approval date: January 30, 2012

    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]


  • Manufacturer: SANDOZ

    Approval date: June 20, 2011

    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]


  • Manufacturer: TEVA

    Approval date: June 20, 2011

    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]


  • Manufacturer: TORRENT PHARMS

    Approval date: June 20, 2011

    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]


  • Manufacturer: WOCKHARDT

    Approval date: June 20, 2011

    Strength(s): 250MG [AB], 500MG [AB], 750MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Levaquin. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents


Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.




  • Taste masked liquid pharmaceutical compositions
    Patent 6,806,256
    Issued: October 19, 2004
    Inventor(s): Stephen A.; Ulrich & Karen R.; Zimm & Marc Karel Jozef; Francois & Willy Maria Albert Carlo; Dries
    Assignee(s): Ortho -McNeil Pharmaceutical, Inc.
    This invention is directed to a taste masked liquid pharmaceutical composition comprising a pharmaceutically active agent and a taste masking composition. In particular, the taste masking composition comprises a taste masking effective amount of an artificial sweetener.
    Patent expiration dates:

    • February 26, 2022
      ✓ 
      Drug product


    • August 26, 2022
      ✓ 
      Pediatric exclusivity



Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:
    • September 10, 2010 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST

    • September 14, 2010 - TREATMENT OF COMPLICATED URINARY TRACT INFECTION AND ACUTE PYELONEPHRITIS WITH LEVAQUIN 750MG ONCE DAILY FOR FIVE DAYS

    • March 10, 2011 - PEDIATRIC EXCLUSIVITY

See also...

  • Levaquin Consumer Information (Drugs.com)
  • Levaquin Consumer Information (Wolters Kluwer)
  • Levaquin Solution Consumer Information (Wolters Kluwer)
  • Levaquin Tablets Consumer Information (Wolters Kluwer)
  • Levaquin Consumer Information (Cerner Multum)
  • Levaquin Advanced Consumer Information (Micromedex)
  • Levaquin Intravenous Advanced Consumer Information (Micromedex)
  • Levaquin AHFS DI Monographs (ASHP)
  • Levofloxacin Consumer Information (Wolters Kluwer)
  • Levofloxacin Solution Consumer Information (Wolters Kluwer)
  • Levofloxacin Tablets Consumer Information (Wolters Kluwer)
  • Levofloxacin Consumer Information (Cerner Multum)
  • Levofloxacin Advanced Consumer Information (Micromedex)
  • Levofloxacin Intravenous Advanced Consumer Information (Micromedex)
  • Levofloxacin AHFS DI Monographs (ASHP)

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