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  81   Abbreviated New Drug Application (ANDA)  

Where should the relevant information on leachables and extractables of container closure system be included in?

  
  82   Abbreviated New Drug Application (ANDA)  

Where should data of constitution or dilution studies performed as part of the formal stability studies to confirm product quality through shelf-life be provided?

  
  83   Abbreviated New Drug Application (ANDA)  

For 3.2.P.3.3 Description of Manufacturing Process and Process Controls, what information is required for chemical drug products?

  
  84   Abbreviated New Drug Application (ANDA)  

What information on the reference standards or materials is required for the registration of generic drugs?

  
  85   Abbreviated New Drug Application (ANDA)  

Rather than repeating information, can only the information of reference standards be provided in 3.2.S.5 once the same information is include in 3.2.P.6?

  
  86   Abbreviated New Drug Application (ANDA)  

Where should the description of overfill for injections be presented?

  
  87   Abbreviated New Drug Application (ANDA)  

Where should the stability protocol and report be presented?

  
  88   Abbreviated New Drug Application (ANDA)  

How many batch files of drug products are required for an ANDA?

  
  89   Abbreviated New Drug Application (ANDA)  

For ANDA registration, which section of CTD format should the batch analyses of the drug product be provided in? Should the analyzed batch be manufactured within 2 years?

  
  90   Abbreviated New Drug Application (ANDA)  

For ANDA registration, whether batch records from each packaging type should be provided, if there are different packaging types (e.g. Alu-Alu PTP blisters and HDPE bottles)?

  
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