# data[].attributes.body
New product not approved by any drug regulatory agency.

(only applies to NDA)

# data[].attributes.body
for the first strength of a product containing a new chemical or biological entity

# data[].attributes.body
New/ generic product approved by at least one drug regulatory agency.

(applies to NDA and GDA)

# data[].attributes.body
For first strength of product containing:

new combination of registered entities

registered entities in new dosage form, new presentation, new formulation

registered entities for new route of administration

new indication, dosage recommendation or patient population

# data[].attributes.body
New/ generic product approved by a reference drug regulatory agency - US, Australia, Canada, Europe, Uk

(applies to NDA and GDA)

# data[].attributes.body
for subsequent strengths of a product that has been registered/ submitted as NDA-1/2.

products name, dosage form, presentation, indication, dosing regimen and patient population should be the same as NDA-1/2.

# data[].attributes.body
Generic product manufactured in India and approved by a reference drug regulatory agency.

(only applies to GDA)