Herpes Labialis

• 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 · 2025-08-22
  FDA Approved: PENCICLOVIR — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approved the original application for penciclovir from Amneal Pharmaceuticals NY LLC, enabling a generic topical antiviral for treating …

• FDA approval · 2024-09-27
  FDA Approved: PENCICLOVIR — Original Application (Padagis Israel Pharmaceuticals Ltd)

  FDA approved the original application (ANDA) for penciclovir topical cream (generic) from Padagis Israel Pharmaceuticals Ltd. for the treatm…

• FDA approval · 2023-10-26
  FDA Approved: DOCOSANOL — Original Application (YYBA Corp)

  The FDA approved an original application (ANDA) for docosanol from YYBA Corp, authorizing the marketing of a generic docosanol product.

• 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…

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• FDA approval · 2023-03-23
  FDA Approved: VALACYCLOVIR — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  FDA approved a supplemental application for valacyclovir from Sun Pharmaceutical Industries, a generic antiviral indicated for herpes infect…

• 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 · 2022-10-07
  FDA Approved: DOCOSANOL — Original Application (H2-Pharma, LLC)

  FDA approved an Original Application for docosanol filed by H2-Pharma, LLC, granting a generic approval for topical treatment of herpes simp…

• FDA approval · 2020-02-28
  FDA Approved: VALACYCLOVIR — Supplemental Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  The FDA approved a supplemental application for valacyclovir from Sun Pharmaceutical Industries, Inc., resulting in changes to the product's…

• FDA approval · 2019-07-25
  FDA Approved: FAMCICLOVIR — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for famciclovir filed by Apotex Corp.

• FDA approval · 2018-11-21
  FDA Approved: DENAVIR — Supplemental Application (Mylan Pharmaceuticals Inc.)

  FDA approved a supplemental application for Denavir (penciclovir) submitted by Mylan Pharmaceuticals Inc., related to its approved topical a…

• FDA approval · 2018-11-19
  FDA Approved: DOCOSANOL — Original Application (Care One (Retail Business Services, LLC.))

  FDA approved an original application for docosanol by Care One, establishing a generic docosanol topical product.

• FDA approval · 2016-03-04
  FDA Approved: FAMCICLOVIR — Supplemental Application (Apotex Corp.)

  FDA approved a supplemental application for Apotex Corp. to market a generic version of famciclovir.

• FDA approval · 2015-11-24
  FDA Approved: XERESE — Supplemental Application (Bausch Health US LLC)

  FDA approved a supplemental application for XERESE (acyclovir and hydrocortisone) by Bausch Health US LLC, resulting in labeling changes.

• 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 · 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 · 2013-05-14
  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 · 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 · 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 · 2007-05-23
  FDA Approved: ABREVA — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for ABREVA (docosanol) from Haleon US Holdings LLC.

• FDA approval · 2007-01-31
  FDA Approved: VALACYCLOVIR — Original Application (SUN PHARMACEUTICAL INDUSTRIES, INC.)

  FDA approved Sun Pharmaceutical Industries' original-application generic valacyclovir (valacyclovir), authorizing its marketing as an antivi…