FAQ
Drugs
All
No. Class Title
  191   Abbreviated New Drug Application (ANDA)  

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

 
  192   Abbreviated New Drug Application (ANDA)  

If the license of a brand-name drug is revoked or cancelled, could the next application follow the regulations of generic drugs?

 
  193   Abbreviated New Drug Application (ANDA)  

According to Subparagraph 2 of Paragraph 1 of Article 4 of Regulations for Registration of Medicinal Products, a generic drug should contain the identical active ingredient(s), dosage form, strength and efficacy as the drug already approved in Taiwan. Is it necessary to have excipients be identical?

 
  194   Abbreviated New Drug Application (ANDA)  

What contents should be presented in CTD Module 1.15: Status of domestic Bioavailability (BA)/ Bioequivalence (BE) Study?

 
  195   Abbreviated New Drug Application (ANDA)  

Is it necessary to submit Common Technical Document (CTD) module 1 to 5 for the registration of generic drugs?

 
  196   Abbreviated New Drug Application (ANDA)  

What is the reference drug for a generic drug?

 
  197   Abbreviated New Drug Application (ANDA)  

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

 
  198   Abbreviated New Drug Application (ANDA)  

How long does the registration of a generic drug take?

 
  199   Abbreviated New Drug Application (ANDA)  

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

 
  200   Abbreviated New Drug Application (ANDA)  

What is a generic drug?

 
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