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Generic Zofran Availability

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: NOVARTIS PHARMS CORP
    Approval date: January 4, 1991
    Strength(s): EQ 2MG BASE/ML

ZOFRAN (ondansetron hydrochloride - solution;oral)

  • Manufacturer: NOVARTIS PHARMS CORP
    Approval date: January 24, 1997
    Strength(s): EQ 4MG BASE/5ML [RLD] [AA]

ZOFRAN (ondansetron hydrochloride - tablet;oral)

  • Manufacturer: NOVARTIS PHARMS CORP
    Approval date: December 31, 1992
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]
  • Manufacturer: NOVARTIS PHARMS CORP
    Approval date: August 27, 1999
    Strength(s): EQ 24MG BASE [RLD] [AB]

Has a generic version of Zofran been approved?

Yes. The following products are equivalent to Zofran:

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: 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]
  • Manufacturer: WEST-WARD PHARMS INT
    Approval date: December 26, 2006
    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 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: December 26, 2006
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: GLENMARK GENERICS
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: IPCA LABS LTD
    Approval date: January 23, 2014
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]
  • Manufacturer: MYLAN
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: NATCO PHARMA LTD
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]
  • Manufacturer: PLIVA HRVATSKA DOO
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: SANDOZ
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]
  • Manufacturer: SUN PHARM INDS (IN)
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB]
  • Manufacturer: TEVA
    Approval date: June 25, 2007
    Strength(s): EQ 4MG BASE [AB], EQ 8MG BASE [AB], EQ 24MG BASE [AB]

Note: No generic formulation of the following product is available.

  • ondansetron hydrochloride - injectable;injection

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.

Glossary

TermDefinition
Drug PatentA drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug ExclusivityExclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLDA Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.
AAProducts in conventional dosage forms not presenting bioequivalence problems. Products coded as AA contain active ingredients and dosage forms that are not regarded as presenting either actual or potential bioequivalence problems or drug quality or standards issues. However, all oral dosage forms must, nonetheless, meet an appropriate in vitro bioequivalence standard that is acceptable to the Agency in order to be approved.
ABProducts meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (i.e., identical active ingredients(s), dosage form, and route(s) of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against.
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