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NDA 21797/S002 NDA 21798/S002 Page 3BaracludeRx only() () Tablets () Oral Solution Patient Information IncludedWARNINGS Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases,
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What is nda 21-797s-002?
NDA 21-797s-002 is a specific submission form used by the FDA for reporting certain information related to New Drug Applications in the pharmaceutical field.
Who is required to file nda 21-797s-002?
Pharmaceutical companies and other stakeholders involved in the development and marketing of new drugs are required to file NDA 21-797s-002 with the FDA.
How to fill out nda 21-797s-002?
To fill out NDA 21-797s-002, one must provide accurate details about the drug, including indications, dosage, formulation, manufacturing processes, and any relevant clinical data.
What is the purpose of nda 21-797s-002?
The purpose of NDA 21-797s-002 is to facilitate the FDA's review and approval process for new drugs by providing essential data regarding their safety and efficacy.
What information must be reported on nda 21-797s-002?
The information that must be reported on NDA 21-797s-002 includes drug composition, manufacturing details, proposed labeling, clinical trial results, and any adverse effects observed during trials.
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