APPLICATION
ANDA203232
TYPE
ANDA
ORIGINAL APPROVAL
2018-01-26
LATEST ACTION
2022-08-31
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TENOFOVIR DISOPROXIL FUMARATEPrescription
TENOFOVIR DISOPROXIL FUMARATE 300MG · TABLET · ORAL
Approval history
2022-08-31Manufacturing (CMC) · Supplement 16 · unknownAP
2020-01-07Labeling · Supplement 7 · standardAP
2020-01-07Labeling · Supplement 11 · standardAP
2020-01-07Labeling · Supplement 6 · standardAP
2018-01-26UNKNOWN · 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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