UNDERSTANDING AND REQUIREMENTS OF ANDA (ABBREVIATED NEW DRUG APPLICATION) SUBMISSION RTR (REFUSE TO RECEIVE) STANDARDS OF USFDA

Generic drug which is filed as ANDA for US authority by applicant. Generally, once applicant Files ANDA to US FDA after prior review they will provide Acceptance letter which is for the Submission is accepted for further review and facility audit. In other face if our ANDA has insufficient information, we will get RTR (Refuse to Receive).Once we receive RTR, it will be difficult task get the approval of generic product from the US FDA. My project discuss about the basic reasons to face RTR and detail description to avoid RTR issues. In this we discussed about deficiencies through modules wise and to save time and money from the repeated deficiencies. Solid dosage forms (Tablets) are taken as an example to discuss all the detailed studies of modules.