FdaApplication

ANDA 219511

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Identifiers

Properties

PropertyValue
applicant_nameMICRO LABS LTD
application_typeANDA
approval_date2026-01-08

Products (2)

ProductActive ingredientStrengthDosage form
SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE100MG/PACKETFOR SOLUTION;ORAL
SAPROPTERIN DIHYDROCHLORIDESAPROPTERIN DIHYDROCHLORIDE500MG/PACKETFOR SOLUTION;ORAL

2 products