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Standard Pharmaceutical Product Information (Rx Product Only)Introduction Type:New ItemxPRODUCT INFORMATION Company Name: AuroMedics Pharma LLC Application Number for NDA/ANDA/BLA (drug); PMA/510(k)(med
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How to fill out abbreviated new drug application
How to fill out abbreviated new drug application
01
Obtain the required forms from the Food and Drug Administration (FDA).
02
Provide all the necessary information about the drug product, including its active ingredients, dosage forms, manufacturing process, and labeling.
03
Submit the completed application along with any supporting documents to the FDA.
04
Respond to any requests for additional information or clarification from the FDA.
05
Await the FDA's decision on the approval of the abbreviated new drug application.
Who needs abbreviated new drug application?
01
Companies looking to market a generic version of a brand-name drug, once its patent has expired, need to submit an abbreviated new drug application.
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What is abbreviated new drug application?
An abbreviated new drug application (ANDA) is a request to the FDA for approval to market a generic drug that is similar to a brand-name drug, with the same dosage form, strength, and route of administration.
Who is required to file abbreviated new drug application?
Manufacturers seeking to market a generic version of an already approved branded drug are required to file an ANDA with the FDA.
How to fill out abbreviated new drug application?
To fill out an ANDA, applicants must complete a series of forms provided by the FDA, providing information on the drug's chemistry, manufacturing, controls, labeling, and proof of bioequivalence to the reference listed drug.
What is the purpose of abbreviated new drug application?
The purpose of an ANDA is to demonstrate that the generic drug is bioequivalent to the branded counterpart, ensuring its safety, effectiveness, and quality.
What information must be reported on abbreviated new drug application?
The ANDA must report information including the drug's composition, manufacturing process, labeling, bioavailability studies, and any relevant patent information.
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