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Development and Review Process of NDA, ANDA/AADA and OTC Dr. Basavaraj K. Nanjwade  M. Pharm.,  Ph. D Associate Professor Department of Pharmaceutics KLE University BELGAUM – 590 010
New Drug Development Process
Fundamentals of NDA Submissions ,[object Object],[object Object],[object Object],[object Object],[object Object]
Fundamentals of NDA Submissions ,[object Object],[object Object],[object Object],[object Object]
Fundamentals of NDA Submissions ,[object Object],[object Object],[object Object],[object Object],[object Object]
New Drug Application (NDA) Classifications ,[object Object],[object Object],[object Object],[object Object]
New Drug Application (NDA) Classifications ,[object Object],[object Object],[object Object]
NDA   Review Process
ANDA/AADA (Abbreviated New Drug Application) ,[object Object]
ANDA/AADA (Abbreviated New Drug Application) ,[object Object],[object Object],[object Object]
ANDA/AADA (Abbreviated New Drug Application) ,[object Object],[object Object]
ANDA/AADA Review Process
OTC (Over-the-Counter Drug Products) ,[object Object],[object Object],[object Object]
OTC (Over-the-Counter Drug Products) ,[object Object],[object Object],[object Object]
OTC Drug Monograph Review Process
THANK YOU E-mail:  [email_address] Cell No: 09448716277

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