Preliminary requirement for filing application in US

  • Snehal Shah
  • Jitendra Kumar Badjatya

Abstract

USFDA is very critical regulated agency for submission. This review reveals how to submit an Abbreviated New Drug Application (ANDA) as per FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).ANDA Submission contains data which when submitted to FDA's CDER, Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product.
Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the public. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

Keywords: Orange Book, CDER, ANDA, FDA, Paragraph IV, certifications, clauses, RTR

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How to Cite
Shah, S., and J. Badjatya. “Preliminary Requirement for Filing Application in US”. International Journal of Drug Regulatory Affairs, Vol. 6, no. 4, Dec. 2018, pp. 1-8, doi:https://doi.org/10.22270/ijdra.v6i4.276.