Comparasion of IND,NDA,BLA,ANDA,OTC

1. Comparision between
IND/NDA/BLA/ANDA/OTC
INA : Investigational new drug
NDA : New drug application
BLA : Biological license application
ANDA : Abbreviated new drug application
OTC : Over the counter
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2. Details
IND NDA BLA ANDA OTC
Covered under FDC Act FDC Act PHS Act
FDC Act, Hatch-
Waxman Act,
BPCIA
FDC Act
Reviewed by CDER/CBER CDER CBER CBER,OGD
CDER(ODE IV)
and FTC
Listed in - Orange book Purple book Orange book
OTC
Monograph
and federal
register
Type of
application
Research Marketing Marketing Marketing Marketing
Data
available/requir
ed
Preclinical ,
CMC, proposed
CT protocol
clinical, CMC ,
proposed
labelling
Clinical , CMC,
proposed
labelling
BA/BE
Additionally
safety studies,
labelling info
Types
Investigator
initiated
emergency
treatment
505(b)(1)
505(b)(2) 351(a)
Generic- 505 (j)
Biosimilar-351(k)
-
Comparision between IND/NDA/BLA/ANDA/OTC