PharmD Info

A forum for Indian Pharmacy Professionals

Find Quality Assurance - Guidelines and SOPs, Role of Quality Assurance in Pharmaceutical Industries and QA Discussion Forum.
Forum rules: General rules are applicable for this forum- Find Here
  • User avatar
#5211
FDA published "Orange Book Questions and Answers".

This guidance is intended to assist prospective and current drug product applicants and approved application holders in effectively using the Orange Book.

The guidance provides answers to commonly asked questions FDA has received from these interested parties regarding the Orange Book and covers topics such as the content and format of the Orange Book, petitioned abbreviated new drug applications (ANDAs), the movement of drug products between the Active and Discontinued sections in the Orange Book, and drug product and patent listings.

#fda #Learning #anda

Download Here
(418.72 KiB) Downloaded 183 times
Similar Topics
Topics Statistics Last post
0 Replies 
2434 Views
by Utkarsh2405
0 Replies 
1757 Views
by AhanaHaroon
0 Replies 
5101 Views
by Utkarsh2405
0 Replies 
1694 Views
by unbreakable
0 Replies 
1419 Views
by Admin

Orange Biotech has established itself as the best […]

PharmD Info - Highlights