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(RLD) in dosage form (capsule vs. tablet), active ingredient (Valerie acid vs. sodium) and is otherwise similar with respect to route of administration, ...
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What is rld in dosage bformb?
RLD stands for Reference Listed Drug. It is the drug product selected by FDA for comparison to the generic drug to determine its equivalence.
Who is required to file rld in dosage bformb?
The manufacturer or sponsor of a generic drug is required to file an Abbreviated New Drug Application (ANDA) containing the RLD information.
How to fill out rld in dosage bformb?
To fill out the RLD in dosage bformb, the manufacturer or sponsor needs to provide detailed information about the reference listed drug, such as its composition, dosage form, strength, and labeling.
What is the purpose of rld in dosage bformb?
The purpose of the RLD in dosage bformb is to establish the safety and efficacy of the generic drug by comparing it to the reference listed drug.
What information must be reported on rld in dosage bformb?
The RLD in dosage bformb must include information about the reference listed drug's active ingredients, dosage form, strength, route of administration, and any additional specifications relevant to the drug product.
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