What is difference between NDA & ANDA ?

What is difference between NDA & ANDA ?..

Answer / b.gangatharan

NDA means New Drug Application,sponsor of new drug must submit evidence of drug safety&effectiveness to meet FDA requirements for marketing approval,hence sponsor submits to FDA a New Drug Application(NDA)......ANDA means Abbreviated New Drug Application which is an application for US generic drug approval for an existing licensed medication or approved drug.
Caplin Point laboratory,

Is This Answer Correct ?    2 Yes 0 No

Post New Answer

More Analytical Chemistry Interview Questions

what is the limit of Correlation for IR test compare to the standard and test

3 Answers   Nakoda Chemicals,

reasons for negative peaks in chromatography

5 Answers   DRL,

Difference between uv detector nd RI DETECTOR? wt s the difference between OVI Solvents nd residual solvents incase of GAS CHROMATOGRAPHY? nd wt s its detection limit?

3 Answers  

How will u perform degradation study in detectors other thann PDA in HPLC Methodology

0 Answers   Micro Labs, Adley,

what is a differance between assay by HPLC and assay by titration?

5 Answers  

In UV we measure absorbance , how it is happend ? explain me

4 Answers  

principle of FTIR

2 Answers   Biocon, Macleods,

If we have a kc is1*10^8 and the .kp 2*10^5 of reaction A------->B C------->D what is the volume of C?

0 Answers  

How can we konw that the HPLC column is endcapped? Is it possible to identify visually without COA?

2 Answers   JBCPL,

Why pyrene is also use for calibration if detector

1 Answers   Cipla, Dr Reddys,

what is the origin to prepare standard operating procedure

0 Answers  

give tha clarity about peak purity concept

3 Answers   Aurobindo, Reliance Life Sciences,

  • Organic Chemistry Interview Questions Organic Chemistry (288)
  • Inorganic Chemistry Interview Questions Inorganic Chemistry (113)
  • Analytical Chemistry Interview Questions Analytical Chemistry (1215)
  • Physical Chemistry Interview Questions Physical Chemistry (62)
  • General Chemistry Interview Questions General Chemistry (300)
  • Chemistry AllOther Interview Questions Chemistry AllOther (77)