Herpes Simplex Infection

• FDA approval · 2025-11-12
  FDA Approved: VALTREX — Supplemental Application (GlaxoSmithKline LLC)

  FDA approved a supplemental application for Valtrex (valacyclovir hydrochloride) filed by GlaxoSmithKline LLC under NDA020487. The action up…

• FDA approval · 2023-05-11
  FDA Approved: VALACYCLOVIR HYDROCHLORIDE — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for valacyclovir hydrochloride (generic valacyclovir) from Mylan Pharmaceuticals Inc., under AND…

• FDA approval · 2023-02-28
  FDA Approved: ACYCLOVIR — Original Application (Viona Pharmaceuticals Inc)

  The FDA approved an Original Application (ANDA) for acyclovir by Viona Pharmaceuticals Inc, establishing a generic version of the antiviral …

• FDA approval · 2022-11-09
  FDA Approved: PENCICLOVIR — Original Application (Teva Pharmaceuticals USA, Inc.)

  FDA approved the original application for penciclovir from Teva Pharmaceuticals USA, Inc. (ANDA212710), a generic topical antiviral.

• FDA approval · 2021-05-19
  FDA Approved: ACYCLOVIR — Original Application (Macleods Pharmaceuticals Limited)

  FDA approved the original ANDA for acyclovir from Macleods Pharmaceuticals Limited, enabling a generic version of acyclovir to enter the mar…

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• FDA approval · 2020-04-23
  FDA Approved: ACYCLOVIR — Original Application (Chartwell Governmental & Specialty RX, LLC.)

  The FDA approved Chartwell Governmental & Specialty RX, LLC.'s generic acyclovir via ANDA 212718, confirming a generic antiviral product. It…

• FDA approval · 2018-04-06
  FDA Approved: ACYCLOVIR — Original Application (Alembic Pharmaceuticals Inc.)

  FDA approves Alembic Pharmaceuticals Inc.'s original ANDA for acyclovir, granting a generic version of the antiviral for herpes simplex infe…

• FDA approval · 2016-03-25
  FDA Approved: ACYCLOVIR — Original Application (Viona Pharmaceuticals Inc)

  FDA approves the original application for acyclovir from Viona Pharmaceuticals Inc, making a generic version of acyclovir available.

• FDA approval · 2014-06-18
  FDA Approved: ACYCLOVIR — Original Application (Amneal Pharmaceuticals LLC)

  FDA approved Amneal Pharmaceuticals' original application for a generic acyclovir product.

• 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 · 2009-12-07
  FDA Approved: ACYCLOVIR — Supplemental Application (Aurobindo Pharma Limited)

  FDA approves a supplemental application for acyclovir from Aurobindo Pharma Limited.