Question
Biopharmaceutics and Pharmacokinetics Question on Bio-availability & Bio-equivalence
A Pharmaceutical company plans to market a generic version of a drug produce whose patent has expired has expire Which type of documentation must be submitted to the FDA
A
IND
B
NDA
C
ANDA
D
SNDA & Letter of intent
Answer
ANDA
Explanation
Solution
The correct option is (C) :ANDA