APPLICATION
ANDA211335
TYPE
ANDA
ORIGINAL APPROVAL
2019-03-26
LATEST ACTION
2021-01-07
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TADALAFILPrescription
TADALAFIL 10MG · TABLET · ORAL
TADALAFILPrescription
TADALAFIL 2.5MG · TABLET · ORAL
TADALAFILPrescription
TADALAFIL 20MG · TABLET · ORAL
TADALAFILPrescription
TADALAFIL 5MG · TABLET · ORAL
Approval history
2021-01-07Labeling · Supplement 2 · standardAP
2019-03-26UNKNOWN · Original · 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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