• Pooja Sonyabapu Masal
• Ulka Mote

The New Drug Application (NDA) is the vehicle in the United States through which drug sponsors formally propose that the Food and Drug Administration (FDA) approve a new pharmaceutical for sale and marketing. Since 1938, every new drug has been the subject of an approved NDA before U.S. commercialization. The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA . An abbreviated new drug application (ANDA) is Specifically designed for an approval of generic drug product. Application for products similar to “already approved drugs” in terms of same dosage form, same route of administration, active ingredients and other conditions Such applications were required to show bioequivalence if FDA thought the products have potential bioavailability problem. All approved products both generic and innovator, are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).Generic drug applications are termed as “abbreviated” because they are generally not required to include preclinical and clinical data to establish safety and effectiveness.

NDA, ANDA, FDA

"A REVIEW : THE NEW DRUG APPLICATION AND ABBREVIATED NEW DRUG APPLICATION ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org), ISSN:2349-5162, Vol.11, Issue 1, page no.g149-g168, January-2024, Available :http://www.jetir.org/papers/JETIR2401619.pdf

"A REVIEW : THE NEW DRUG APPLICATION AND ABBREVIATED NEW DRUG APPLICATION ", International Journal of Emerging Technologies and Innovative Research (www.jetir.org | UGC and issn Approved), ISSN:2349-5162, Vol.11, Issue 1, page no. ppg149-g168, January-2024, Available at : http://www.jetir.org/papers/JETIR2401619.pdf