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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214053
Company: APOTEX
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 120MG;EQ 15MG BASE TABLET;ORAL Prescription AB No No
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 200MG;EQ 25MG BASE TABLET;ORAL Prescription AB No No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
05/17/2024 ORIG-1 Approval STANDARD

Label is not available on this site.

EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE

TABLET;ORAL; 120MG;EQ 15MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESCOVY EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 120MG;EQ 15MG BASE TABLET;ORAL Prescription Yes AB 208215 GILEAD SCIENCES INC
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 120MG;EQ 15MG BASE TABLET;ORAL Prescription No AB 214053 APOTEX

TABLET;ORAL; 200MG;EQ 25MG BASE
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
DESCOVY EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 200MG;EQ 25MG BASE TABLET;ORAL Prescription Yes AB 208215 GILEAD SCIENCES INC
EMTRICITABINE AND TENOFOVIR ALAFENAMIDE FUMARATE EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE 200MG;EQ 25MG BASE TABLET;ORAL Prescription No AB 214053 APOTEX
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