abbreviated new drug application(English)

• intended for generic approval. Generic drug products are defined as drug products that are identical to an innovative (brand-name) drug which is the subject of an approved NDA with regard to active ingredient(s), route of administration, dosage form, strength, and conditions of use
• BE, FDA, NDA, OTA, COPQ
• Pharmacology / pharmaceutics, Health care industry
• https://doi.org….1002/wics.1310
• https://doi.org…16813-4.18001-8