1.

What Are The Differences Between Nda And 505 (b)(2) Application?

Answer»

New Drug Application (NDA) :

  • All investigations relied on by applicant for APPROVAL were conducted by/for applicant and for which applicant has right of reference.
  • Generally, filed for newly INVENTED pharmaceuticals.

505 (b)(2) Application :

  • One or more investigation relied on by applicant for approval were not conducted by/for applicant and for which applicant has not OBTAINED a right of reference.
  • Generally, filed for new dosage form, new route of administration, new indication etc for all already APPROVED pharmaceutical.

 

New Drug Application (NDA) :

505 (b)(2) Application :

 


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