Where can I look for ANDA application on US FDA site
I have picked up one drug from Gland Pharma
First I have looked up on FDA Orange Book , took the chemical entity name and then looked up the below site
I can’t find any Gland Pharma reference anywhere in the document and unable to locate the original ANDA application.
I am trying to understand all the parties involved to manufacture this medicine, API providers, syringe providers etc…
One more observation is Gland reported it on 4th May 2002 that they have approval from USFDA where as on the US FDA site it shows it is approved in 2013 .
@harsh.beria93 or any pharma experts please help me to understand this better
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