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FDA ANDA · ANDA090141

TADALAFIL

Sponsor: TEVA PHARMS USA

APPLICATION
ANDA090141
TYPE
ANDA
ORIGINAL APPROVAL
2018-05-22
LATEST ACTION
2023-02-15
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

TADALAFILPrescription
TADALAFIL 20MG · TABLET · ORAL
TADALAFILPrescription
TADALAFIL 5MG · TABLET · ORAL
TADALAFILPrescription
TADALAFIL 10MG · TABLET · ORAL
TADALAFILPrescription
TADALAFIL 2.5MG · TABLET · ORAL

Approval history

2023-02-15Labeling · Supplement 7 · standardAP
2018-05-22OriginalLetterAP
VIEW ON DRUGS@FDA ↗

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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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