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FDA ANDA · ANDA211148
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE
Sponsor: MYLAN LABS LTD
APPLICATION
ANDA211148
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
None (Tentative Approval)
Products
EMTRICITABINE AND TENOFOVIR ALAFENAMIDENone (Tentative Approval)
EMTRICITABINE, TENOFOVIR ALAFENAMIDE 120MG · TABLET · ORAL
EMTRICITABINE AND TENOFOVIR ALAFENAMIDENone (Tentative Approval)
EMTRICITABINE, TENOFOVIR ALAFENAMIDE 15MG · TABLET · ORAL
EMTRICITABINE AND TENOFOVIR ALAFENAMIDENone (Tentative Approval)
EMTRICITABINE, TENOFOVIR ALAFENAMIDE 200MG · TABLET · ORAL
EMTRICITABINE AND TENOFOVIR ALAFENAMIDENone (Tentative Approval)
EMTRICITABINE, TENOFOVIR ALAFENAMIDE 25MG · TABLET · ORAL
EMTRICITABINE AND TENOFOVIR ALAFENAMIDENone (Tentative Approval)
EMTRICITABINE, TENOFOVIR ALAFENAMIDE 10MG · TABLET · ORAL
Approval history
2024-01-02UNKNOWN · Original · standardTA
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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