APPLICATION
ANDA208213
TYPE
ANDA
ORIGINAL APPROVAL
2018-11-23
LATEST ACTION
2023-04-04
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
ROFLUMILASTPrescription
ROFLUMILAST 250MCG · TABLET · ORAL
ROFLUMILASTPrescription
ROFLUMILAST 500MCG · TABLET · ORAL
Approval history
2023-04-04Labeling · Supplement 3 · standardAP
Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.
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