Genital Herpes

• FDA approval · 2015-10-26
  FDA Approved: VALACYCLOVIR — Supplemental Application (Quallent Pharmaceuticals Health LLC)

  The FDA approved a supplemental application for Valacyclovir submitted by Quallent Pharmaceuticals Health LLC. The action confirms regulator…

• FDA approval · 2015-08-20
  FDA Approved: ACYCLOVIR — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for acyclovir from Amneal Pharmaceuticals LLC, supporting a generic formulation of acyclovir.

• FDA approval · 2015-04-08
  FDA Approved: VALACYCLOVIR — Original Application (Quallent Pharmaceuticals Health LLC)

  FDA approved Quallent Pharmaceuticals Health LLC's original ANDA for Valacyclovir, providing a generic option for treating common herpes inf…

• FDA approval · 2014-10-24
  FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for Valacyclovir hydrochloride from Aurobindo Pharma Limited, granting approval of a generic product…

• FDA approval · 2014-09-10
  FDA Approved: FAMCICLOVIR — Original Application (Camber Pharmaceuticals, Inc.)

  FDA approved a generic version of famciclovir under an original ANDA from Camber Pharmaceuticals, Inc.

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• FDA approval · 2014-08-19
  FDA Approved: ACYCLOVIR — Original Application (Zydus Pharmaceuticals (USA) Inc.)

  FDA approved the original (ANDA) application for a generic acyclovir product from Zydus Pharmaceuticals (USA) Inc., enabling a generic versi…

• FDA approval · 2014-04-01
  FDA Approved: ACYCLOVIR — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for acyclovir from Teva Pharmaceuticals USA, Inc., updating the drug’s approval details. The supplem…

• FDA approval · 2014-03-06
  FDA Approved: ACYCLOVIR — Original Application (Nivagen Pharmaceuticals, Inc.)

  FDA approved the original ANDA for acyclovir from Nivagen Pharmaceuticals, authorizing a generic version of the antiviral for several herpes…

• FDA approval · 2013-11-15
  FDA Approved: ACYCLOVIR — Original Application (Modavar Pharmaceuticals LLC)

  FDA approved Modavar Pharmaceuticals LLC's original ANDA for acyclovir, enabling a generic version of the antiviral for common herpes simple…

• FDA approval · 2013-07-23
  FDA Approved: FAMCICLOVIR — Supplemental Application (Aurobindo Pharma Limited)

  FDA approved a supplemental application for a generic famciclovir from Aurobindo Pharma Limited.

• FDA approval · 2013-05-30
  FDA Approved: FAMCICLOVIR — Supplemental Application (Macleods Pharmaceuticals Limited)

  The FDA approved a supplemental application for famciclovir from Macleods Pharmaceuticals Limited, authorizing an update to the approved AND…

• FDA approval · 2013-05-14
  FDA Approved: VALACYCLOVIR — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  FDA approved a supplemental application for VALACYCLOVIR from Sun Pharmaceutical Industries, Inc., under an approved ANDA.

• FDA approval · 2013-03-20
  FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Supplemental Application (TIME CAP LABORATORIES, INC.)

  FDA approved a supplemental application for valacyclovir hydrochloride from Time Cap Laboratories, Inc. The action finalizes the regulatory …

• FDA approval · 2013-03-15
  FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Supplemental Application (Aurobindo Pharma Limited)

  The FDA approved a supplemental application for Valacyclovir hydrochloride from Aurobindo Pharma Limited. This action supports the continued…

• FDA approval · 2013-01-17
  FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Supplemental Application (TIME CAP LABORATORIES, INC.)

  FDA approved a supplemental application for valacyclovir hydrochloride from Time Cap Laboratories, Inc.

• FDA approval · 2012-04-03
  FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Original Application (Jubilant Cadista Pharmaceuticals Inc.)

  FDA approved a generic valacyclovir hydrochloride product from Jubilant Cadista Pharmaceuticals Inc. The approval covers indications for tre…

• FDA approval · 2012-01-12
  FDA Approved: FAMCICLOVIR — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original ANDA for famciclovir from Macleods Pharmaceuticals Limited, establishing a generic version of the antiviral. The d…

• FDA approval · 2011-05-09
  FDA Approved: FAMCICLOVIR — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved a supplemental application for famciclovir from Teva Pharmaceuticals USA, Inc., updating the regulatory status for the generic …

• FDA approval · 2011-03-21
  FDA Approved: FAMCICLOVIR — Original Application (Aurobindo Pharma Limited)

  The FDA approved Aurobindo Pharma Limited's generic famciclovir under an Original Application (ANDA), authorizing its sale in the United Sta…

• FDA approval · 2010-05-24
  FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Original Application (Mylan Pharmaceuticals Inc.)

  FDA approved the original application for valacyclovir hydrochloride (valacyclovir) by Mylan Pharmaceuticals Inc., a generic antiviral. The …

• FDA approval · 2010-05-24
  FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Original Application (TIME CAP LABORATORIES, INC.)

  FDA approved Valacyclovir hydrochloride from Time Cap Laboratories under an Original Abbreviated New Drug Application.

• FDA approval · 2010-05-24
  FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Original Application (Aurobindo Pharma Limited)

  FDA approves a generic valacyclovir hydrochloride product from Aurobindo Pharma Limited under an Original Application (ANDA). It is indicate…

• FDA approval · 2010-04-19
  FDA Approved: VALTREX — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Valtrex (valacyclovir hydrochloride) submitted by GlaxoSmithKline LLC.

• FDA approval · 2009-04-29
  FDA Approved: FAMCICLOVIR — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved a Teva Pharmaceuticals supplemental application for famciclovir, resulting in an updated indication/label for the generic a…

• FDA approval · 2007-12-11
  FDA Approved: VALTREX — Supplemental Application (GlaxoSmithKline LLC)

  The FDA approved a supplemental application for Valtrex (valacyclovir hydrochloride) submitted by GlaxoSmithKline LLC, authorizing changes t…