Herpes Simplex Labialis

• FDA approval · 2026-04-14
  FDA Approved: ABREVA — Supplemental Application (Haleon US Holdings LLC)

  FDA approved a supplemental application for ABREVA (docosanol) submitted by Haleon US Holdings LLC. ABREVA is an OTC topical treatment for h…

• FDA approval · 2024-03-01
  FDA Approved: AMAZON BASICS DOCOSANOL — Original Application (Amazon.com Services LLC)

  FDA approved the original application for AMAZON BASICS DOCOSANOL (docosanol) topical cream.

• FDA approval · 2023-08-28
  FDA Approved: DOCOSANOL — Supplemental Application (Care One (Retail Business Services, LLC.))

  The FDA approved a supplemental application for Docosanol (DOCOSANOL) submitted by Care One (Retail Business Services, LLC.), updating the p…

• FDA approval · 2023-08-07
  FDA Approved: PENCICLOVIR — Original Application (Torrent Pharmaceuticals Limited)

  FDA approves Torrent Pharmaceuticals' generic penciclovir for topical treatment of herpes simplex labialis (cold sores) as an original ANDA.

• FDA approval · 2022-05-03
  FDA Approved: DOCOSANOL — Original Application (Alembic Pharmaceuticals Limited)

  FDA approved the Original Application for docosanol from Alembic Pharmaceuticals Limited.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• FDA approval · 2020-03-18
  FDA Approved: VALACYCLOVIR — Original Application (Westminster Pharmaceuticals, LLC)

  FDA approved Westminster Pharmaceuticals' original ANDA for valacyclovir (valacyclovir hydrochloride), a generic antiviral used to treat her…

• FDA approval · 2015-02-09
  FDA Approved: DENAVIR — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Denavir (penciclovir) submitted by Mylan Pharmaceuticals Inc. This action updates the regula…

• FDA approval · 2015-01-30
  FDA Approved: ABREVA — Supplemental Application (Haleon US Holdings LLC)

  The FDA approved a supplemental application for ABREVA (docosanol) submitted by Haleon US Holdings LLC.

• FDA approval · 2013-09-11
  FDA Approved: DENAVIR — Supplemental Application (Mylan Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Denavir (penciclovir) filed by Mylan Pharmaceuticals, updating the regulatory status of the …

• 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 · 2008-02-08
  FDA Approved: ABREVA — Supplemental Application (Haleon US Holdings LLC)

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

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

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