Wednesday, October 12, 2016

Zofran


See also: Generic Zofran ODT


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


ZOFRAN (ondansetron hydrochloride - injectable; injection)



  • Manufacturer: GLAXOSMITHKLINE

    Approval date: January 4, 1991

    Strength(s): EQ 2MG BASE/ML [RLD][AP]

ZOFRAN (ondansetron hydrochloride - solution; oral)



  • Manufacturer: GLAXOSMITHKLINE

    Approval date: January 24, 1997

    Strength(s): EQ 4MG BASE/5ML [RLD][AA]

ZOFRAN (ondansetron hydrochloride - tablet; oral)



  • Manufacturer: GLAXOSMITHKLINE

    Approval date: December 31, 1992

    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: GLAXOSMITHKLINE

    Approval date: August 27, 1999

    Strength(s): EQ 24MG BASE [RLD][AB]

Has a generic version of Zofran been approved?


A generic version of Zofran 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 Zofran and have been approved by the FDA:


ondansetron hydrochloride injectable; injection



  • Manufacturer: APOTEX

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: APP PHARMS

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: BAXTER HLTHCARE

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: BEDFORD

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: EMCURE PHARMS

    Approval date: April 16, 2010

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: GLAND PHARMA LTD

    Approval date: September 25, 2009

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: HIKMA FARMACEUTICA

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: HOSPIRA

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: HOSPIRA

    Approval date: January 19, 2007

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: LANNETT

    Approval date: April 14, 2010

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: LANNETT

    Approval date: August 5, 2010

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: LUITPOLD

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: LUITPOLD

    Approval date: November 18, 2008

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: PFIZER

    Approval date: April 23, 2008

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: PLIVA HRVATSKA DOO

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: SANDOZ

    Approval date: June 27, 2007

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: SPECTRUM PHARMS

    Approval date: March 26, 2007

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: SUN PHARM INDS (IN)

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: TEVA

    Approval date: November 22, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: WOCKHARDT

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]

ondansetron hydrochloride solution; oral



  • Manufacturer: AMNEAL PHARMS

    Approval date: January 31, 2011

    Strength(s): EQ 4MG BASE/5ML [AA]


  • Manufacturer: APOTEX

    Approval date: June 25, 2007

    Strength(s): EQ 4MG BASE/5ML [AA]


  • Manufacturer: AUROBINDO PHARMA

    Approval date: November 28, 2007

    Strength(s): EQ 4MG BASE/5ML [AA]


  • Manufacturer: ROXANE

    Approval date: December 26, 2006

    Strength(s): EQ 4MG BASE/5ML [AA]


  • Manufacturer: SILARX

    Approval date: January 27, 2011

    Strength(s): EQ 4MG BASE/5ML [AA]


  • Manufacturer: TARO

    Approval date: November 30, 2007

    Strength(s): EQ 4MG BASE/5ML [AA]

ondansetron hydrochloride tablet; oral



  • Manufacturer: APOTEX

    Approval date: June 25, 2007

    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: AUROBINDO PHARMA

    Approval date: July 31, 2007

    Strength(s): EQ 24MG BASE [AB], EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: DR REDDYS LABS LTD

    Approval date: December 26, 2006

    Strength(s): EQ 24MG BASE [AB], EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: GLENMARK GENERICS

    Approval date: June 25, 2007

    Strength(s): EQ 24MG BASE [AB], EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: MYLAN

    Approval date: June 25, 2007

    Strength(s): EQ 24MG BASE [AB], EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: NATCO PHARMA LTD

    Approval date: June 25, 2007

    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: PAR PHARM

    Approval date: June 25, 2007

    Strength(s): EQ 24MG BASE [AB], EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: PLIVA HRVATSKA DOO

    Approval date: June 25, 2007

    Strength(s): EQ 24MG BASE [AB], EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: SANDOZ

    Approval date: June 25, 2007

    Strength(s): EQ 24MG BASE [AB], EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: SUN PHARM INDS (IN)

    Approval date: June 25, 2007

    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: TARO

    Approval date: March 28, 2011

    Strength(s): EQ 24MG BASE [AB], EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: TEVA

    Approval date: June 25, 2007

    Strength(s): EQ 24MG BASE [AB], EQ 4MG BASE [AB], EQ 8MG BASE [AB]


  • Manufacturer: WEST WARD

    Approval date: September 6, 2007

    Strength(s): EQ 24MG BASE [AB], EQ 4MG BASE [AB], EQ 8MG BASE [AB]

ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE (ondansetron hydrochloride injectable; injection)



  • Manufacturer: APOTEX INC

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: APP PHARMS

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: BAXTER HLTHCARE

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: BEDFORD LABS

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: HIKMA FARMACEUTICA

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: HOSPIRA

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: LUITPOLD

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: LUITPOLD

    Approval date: November 18, 2008

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: PFIZER

    Approval date: April 23, 2008

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: SANDOZ

    Approval date: June 27, 2007

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: SUN PHARM INDS LTD

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: TARO PHARMS IRELAND

    Approval date: March 21, 2008

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: TEVA

    Approval date: November 22, 2006

    Strength(s): EQ 2MG BASE/ML [AP]


  • Manufacturer: WOCKHARDT

    Approval date: December 26, 2006

    Strength(s): EQ 2MG BASE/ML [AP]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Zofran. 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.




  • Process and composition using ondansetron
    Patent 5,344,658
    Issued: September 6, 1994
    Inventor(s): Collin; David T.
    Assignee(s): Glaxo Group Limited
    The invention relates to a process for reducing the crystal size of ondansetron hydrochloride dihydrate produced by crystallisation from solvent to a size which is suitable for effective distribution in a tablet blend, in particular 100% less that 250 .mu.m. The ondansetron hydrochloride dihydrate is desolvated by drying at elevated temperature and reduced or atmospheric pressure and is then rehydrated.
    Patent expiration dates:

    • September 6, 2011


    • March 6, 2012
      ✓ 
      Pediatric exclusivity




  • Oral compositions containing ondansetron
    Patent 5,854,270
    Issued: December 29, 1998
    Inventor(s): Gambhir; Renu
    Assignee(s): Glaxo Wellcome Inc.
    The invention relates to a liquid composition for oral administration comprising ondansetron or a pharmaceutically acceptable derivative thereof, a sweetener and one or more pharmaceutically acceptable excipients. The sweetener comprises one or more polyhydric alcohols and the pH of the combination lies in the range 2.0 to 5.0. Methods for the manufacture of such compositions and for their use in the treatment of conditions mediated through the action of 5-hydroxytryptamine (5 HT) at 5 HT.sub.3 receptors are also included.
    Patent expiration dates:

    • November 20, 2015
      ✓ 
      Patent use: RELIEF OF NAUSEA AND VOMITING
      ✓ 
      Drug product


    • May 20, 2016
      ✓ 
      Pediatric exclusivity



See also...

  • Zofran Consumer Information (Drugs.com)
  • Zofran Consumer Information (Wolters Kluwer)
  • Zofran Solution Consumer Information (Wolters Kluwer)
  • Zofran Tablets Consumer Information (Wolters Kluwer)
  • Zofran Consumer Information (Cerner Multum)
  • Zofran injection Consumer Information (Cerner Multum)
  • Zofran Advanced Consumer Information (Micromedex)
  • Zofran Oral, Oromucosal Advanced Consumer Information (Micromedex)
  • Zofran AHFS DI Monographs (ASHP)
  • Ondansetron Consumer Information (Drugs.com)
  • Ondansetron Consumer Information (Wolters Kluwer)
  • Ondansetron Orally Disintegrating Tablets Consumer Information (Wolters Kluwer)
  • Ondansetron Soluble Film Consumer Information (Wolters Kluwer)
  • Ondansetron Solution Consumer Information (Wolters Kluwer)
  • Ondansetron Tablets Consumer Information (Wolters Kluwer)
  • Ondansetron Consumer Information (Cerner Multum)
  • Ondansetron injection Consumer Information (Cerner Multum)
  • Ondansetron Oral, Injection, Intravenous Advanced Consumer Information (Micromedex)
  • Ondansetron Oral, Oromucosal Advanced Consumer Information (Micromedex)
  • Ondansetron Hydrochloride AHFS DI Monographs (ASHP)

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