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Abbreviated New Drug Application (ANDA)

An Abbreviated New Drug Application (ANDA) is submitted to FDA for the review and ultimate approval of a generic drug product. A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use.

Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. 

ANDA review process includes

  • Labeling
  • Pharmacology and Toxicology
  • Chemistry
  • Manufacturing
  • Controls
  • Microbiology
  • Inspection
  • Testing
  • Bioequivalence

LMG will assist you throughout the ANDA process, our services include-

  • Assist you in developing study protocols
  • Prepare your manufacturing facility for FDA plant inspection
  • Assist you in preparing the submission
  • Prepare you for participate in FDA review meetings
  • Participate in FDA review meeting if needed

ANDA approval processes flow chart
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