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Generic Cardene Availability

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

CARDENE (nicardipine hydrochloride - capsule;oral)

  • Manufacturer: CHIESI USA INC
    Approval date: December 21, 1988
    Strength(s): 20MG, 30MG

CARDENE (nicardipine hydrochloride - injectable;injection)

  • Manufacturer: CHIESI USA INC
    Approval date: January 30, 1992
    Strength(s): 25MG/10ML (2.5MG/ML) [RLD] [AP]

Has a generic version of Cardene been approved?

Yes. The following products are equivalent to Cardene:

nicardipine hydrochloride injectable;injection

  • Manufacturer: EUROHLTH INTL SARL
    Approval date: December 28, 2009
    Strength(s): 25MG/10ML (2.5MG/ML) [AP]
  • Manufacturer: EXELA PHARMA SCIENCE
    Approval date: July 24, 2008
    Strength(s): 25MG/10ML (2.5MG/ML) [AP]
  • Manufacturer: LUITPOLD PHARMS INC
    Approval date: November 17, 2009
    Strength(s): 25MG/10ML (2.5MG/ML) [AP]
  • Manufacturer: MYLAN INSTITUTIONAL
    Approval date: November 17, 2009
    Strength(s): 25MG/10ML (2.5MG/ML) [AP]
  • Manufacturer: NAVINTA LLC
    Approval date: November 17, 2009
    Strength(s): 25MG/10ML (2.5MG/ML) [AP]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: November 17, 2009
    Strength(s): 25MG/10ML (2.5MG/ML) [AP]
  • Manufacturer: WOCKHARDT
    Approval date: November 17, 2009
    Strength(s): 25MG/10ML (2.5MG/ML) [AP]

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

  • nicardipine hydrochloride - capsule;oral

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cardene. 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.
APInjectable aqueous solutions and, in certain instances, intravenous non-aqueous solutions. It should be noted that even though injectable (parenteral) products under a specific listing may be evaluated as therapeutically equivalent, there may be important differences among the products in the general category, Injectable; Injection. For example, some injectable products that are rated therapeutically equivalent are labeled for different routes of administration. In addition, some products evaluated as therapeutically equivalent may have different preservatives or no preservatives at all. Injectable products available as dry powders for reconstitution, concentrated sterile solutions for dilution, or sterile solutions ready for injection are pharmaceutical alternative drug products. They are not rated as therapeutically equivalent (AP) to each other even if these pharmaceutical alternative drug products are designed to produce the same concentration prior to injection and are similarly labeled. Consistent with accepted professional practice, it is the responsibility of the prescriber, dispenser, or individual administering the product to be familiar with a product's labeling to assure that it is given only by the route(s) of administration stated in the labeling.
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