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CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER:AND 200652Orig1s004 Trade Name:Positron hydrochloride tablets, 0.5 mg and 1.0 sponsor:Him Pharmaceuticals USA Inc. (Formerly
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Pharmaceutical companies seeking approval for a generic drug product in the United States market would need to fill out ANDA 200652orig1s004fda.
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ANDA 200652orig1s004fda refers to a specific Abbreviated New Drug Application (ANDA) submission to the FDA for approval of a generic drug.
Pharmaceutical companies or manufacturers seeking to market a generic version of a previously approved drug are required to file ANDA 200652orig1s004fda.
To fill out ANDA 200652orig1s004fda, applicants must complete various forms, provide evidence of bioequivalence, and submit comprehensive data including manufacturing processes and labeling.
The purpose of ANDA 200652orig1s004fda is to seek FDA approval for a generic drug that is therapeutically equivalent to a branded medication.
ANDA 200652orig1s004fda must report detailed information including the drug's composition, manufacturing process, labeling, and data demonstrating that it is bioequivalent to the reference listed drug.
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