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ANDA (Abbriviated New Drug Application)
What is the time frame for approval for ANDA Applications?
If all the submitted information is appropriate and correct, the process takes between 12 and 16 months. If you have any other questions about ANDA, please feel to contact us.
How much is ANDA fee?
ANDA fee for FY 2019 are as below. ANDA fee – $ 178,799 . This fee is applicable for each ANDA. ANDA Program fee – This is the annual for ANDA holder. Large Size $ 1,862,167 Medium Size $ 744,867 Small Size $ 186,217 Large: 20 or more approved ANDAs; Medium: between … Read More
What information should be included for ANDA?
Generally, ANDA includes chemistry, manufacturing, control, bio study and administrative information.
What is a generic drug?
A generic drug is identical–or bio equivalent–to a brand name drug (already approved by FDA) in dosage form, safety, strength, route of administration, quality, performance characteristics and intended use.
Who should file ANDA?
Any companies interested in obtaining generic drug approval should file ANDA.
What is ANDA?
ANDA is the Abbreviated New Drug Application, the FDA’s generic drug approval process.