Viral Hepatitis

• FDA approval · 2018-07-31
  FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Original Application (Chartwell RX, LLC.)

  FDA approved Tenofovir disoproxil fumarate tablets under an Original Application (ANDA) filed by Chartwell RX, LLC.

• FDA approval · 2018-07-30
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) submitted by Gilead Sciences, resulting in an updated lab…

• FDA approval · 2018-04-27
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2018-04-27
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2018-01-26
  FDA Approved: TENOFOVIR DISOPROXIL FUMARATE — Original Application (Strides Pharma Science Limited)

  FDA approved the original application for tenofovir disoproxil fumarate as a generic product manufactured by Strides Pharma Science Limited.

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• FDA approval · 2017-10-13
  FDA Approved: PEGASYS — Supplemental Application (pharmaand GmbH)

  FDA approved a supplemental application for PEGASYS (peginterferon alfa-2a) submitted by pharmaand GmbH.

• FDA approval · 2017-09-25
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for EPIVIR (lamivudine) filed by ViiV Healthcare Company.

• FDA approval · 2017-09-25
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for Epivir (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2017-04-07
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) from Gilead Sciences, Inc.

• FDA approval · 2016-12-14
  FDA Tentative Approval: LAMIVUDINE — Supplemental Application (Strides Pharma Science Limited)

  FDA issued tentative approval for Strides Pharma Science Limited's generic lamivudine under an ANDA, signaling potential US market approval …

• FDA approval · 2016-11-21
  FDA Approved: LAMIVUDINE — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's original ANDA for lamivudine, enabling a generic version of lamivudine to be marketed.

• FDA approval · 2016-11-21
  FDA Approved: LAMIVUDINE — Original Application (Ingenus Pharmaceuticals, LLC)

  The FDA approved a generic lamivudine product under an Original Application filed by Ingenus Pharmaceuticals, LLC.

• FDA approval · 2016-07-20
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2016-03-10
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) from Gilead Sciences, Inc.

• FDA approval · 2016-02-16
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc.

• FDA approval · 2016-02-16
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  The FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) from Gilead Sciences, Inc., updating its labeling as …

• FDA approval · 2016-01-06
  FDA Approved: RIBAVIRIN — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for ribavirin from Aurobindo Pharma Limited, authorizing continued approval and use of the ribavirin…

• FDA approval · 2016-01-06
  FDA Approved: VIRAZOLE — Supplemental Application (Bausch Health US, LLC)

  FDA approved a supplemental application for Virazole (ribavirin) submitted by Bausch Health US, LLC, resulting in labeling changes as part o…

• FDA approval · 2015-09-30
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for Epivir (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2015-05-29
  FDA Approved: VIREAD — Supplemental Application (Gilead Sciences, Inc.)

  FDA approved a supplemental application for VIREAD (tenofovir disoproxil fumarate) submitted by Gilead Sciences, Inc. The action indicates a…

• FDA approval · 2015-03-23
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2015-03-23
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company, indicating changes to its labeling…

• FDA approval · 2015-02-19
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2015-02-19
  FDA Approved: EPIVIR — Supplemental Application (ViiV Healthcare Company)

  The FDA approved a supplemental application for EPIVIR (lamivudine) submitted by ViiV Healthcare Company.

• FDA approval · 2014-12-18
  FDA Approved: LAMIVUDINE — Original Application (Lupin Pharmaceuticals, Inc.)

  FDA approves Lupin Pharmaceuticals' original application for lamivudine as a generic product.