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AND FILING CHECKLIST
AND:APPLICANT:
RELATED APPLICATION(S):
DRUG NAME:
DOSAGE FORM:
LETTER DATE:
RECEIVED DATE:
Type II DMF #:
Therapeutic Code:
Archival Copy:
DR Email:BASIS OF SUBMISSION:
NDA/AND:
FIRM:
RLD:
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What is anda?
Anda stands for Abbreviated New Drug Application, which is a submission to the FDA for generic drugs.
Who is required to file anda?
Any company seeking approval to market a generic drug in the US is required to file an anda.
How to fill out anda?
An anda must be filled out with detailed information about the generic drug, including data on its safety and efficacy.
What is the purpose of anda?
The purpose of an anda is to establish that a generic drug is bioequivalent to a brand-name drug and meets the same quality standards.
What information must be reported on anda?
Information on the generic drug's formulation, manufacturing process, labeling, and testing data must be reported on an anda.
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