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No. Class Title
  1   Abbreviated New Drug Application (ANDA)  

With regards to the eligibility of additional strength biowaiver in Item 3 of dissolution profile comparisons documentation from PK section on the ANDA Refuse to File (RTF) checklist, what document is this item exactly check for?

  
  2   Abbreviated New Drug Application (ANDA)  

With regards to validation report and bioanalytical report in Item 3 and 4 of bioequivalence study documentation from PK section on the ANDA Refuse to File (RTF) checklist, how the applicant to confirm if the documentation meets the requirement?

  
  3   Drug Substance  

What documents should be submitted for the registration of a drug substance (API)?

  
  4   Abbreviated New Drug Application (ANDA)  

What information is required on the package inserts of a generic drug?

  
  5   Abbreviated New Drug Application (ANDA)  

How much is the user fee for a generic drug registration?

  
  6   Abbreviated New Drug Application (ANDA)  

How long does the registration of a generic drug take?

  
  7   Abbreviated New Drug Application (ANDA)  

What documents should be submitted for the registration of a generic drug?

  
  8   Drug Substance  

On the API Registration and DMF Refuse to File (RTF) checklist, what information should be provided when submitting an application for a mixture of drug substance and excipient(s) (API mix)?

  
  9   Drug Substance  

On the API Registration and DMF Refuse to File (RTF) checklist, with regards to item 7 on the Type III checklist which states “Are drug substance and intermediate specifications, analytical procedures and certificates of analysis provided?”, what information should be provided?

  
  10   Drug Substance  

On the API Registration and DMF Refuse to File (RTF) checklist, what information should be provided for item 2 on the Type II checklist regarding referenced DMF?

  
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