fda guidance on anda filing, page-18

Don't know the historical success rate for individuals filing and that would be up to the preparation/expertise of the individual to submit properly. But from the Dr Reddy's side below are some interesting facts that may lend an understanding as to how much they deal with, and know the filing and approval process:

Dr Reddy's:

Regulatory Strengths
Ranked No. 3 in US DMF filings Globally
Ranked No. 1 in US DMF filings from India
Dr. Reddy‟s has
127 Active US DMFs
50 Canadian DMFs
69 EDMFs
21 CEPs

Six USFDA approved plants in India
One USFDA approved plantin Mexico
One USFDA inspected plant in Mirfield,UK