Xerostomia

• FDA approval · 2026-03-11
  FDA Approved: CEVIMELINE HYDROCHLORIDE — Original Application (Zydus Lifesciences Limited)

  FDA approves cevimeline hydrochloride as an original ANDA submission from Zydus Lifesciences Limited.

• FDA approval · 2025-07-24
  FDA Approved: CEVIMELINE HYDROCHLORIDE — Supplemental Application (Rising Pharma Holdings, Inc.)

  FDA approved a supplemental application for cevimeline hydrochloride from Rising Pharma Holdings, Inc., confirming changes to the product's …

• FDA approval · 2023-04-06
  FDA Approved: CEVIMELINE HYDROCHLORIDE — Original Application (Advagen Pharma Ltd)

  FDA approves Advagen Pharma Ltd's cevimeline hydrochloride as an original application. It is indicated for the treatment of xerostomia in Sj…

• FDA approval · 2020-09-21
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Original Application (Amneal Pharmaceuticals NY LLC)

  FDA approves Amneal Pharmaceuticals NY LLC's pilocarpine hydrochloride under an original generic application.

• FDA approval · 2015-09-10
  FDA Approved: SALAGEN — Supplemental Application (Advanz Pharma (US) Corp.)

  FDA approved a supplemental application for SALAGEN (pilocarpine hydrochloride) filed by Advanz Pharma (US) Corp. The approval updates the p…

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• FDA approval · 2014-01-27
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for pilocarpine hydrochloride (Sandoz Inc) to update its labeling with additional indications.

• FDA approval · 2013-07-08
  FDA Approved: CEVIMELINE HYDROCHLORIDE — Original Application (Hikma Pharmaceuticals USA Inc.)

  FDA approved cevimeline hydrochloride (oral) as an original application generic product for the treatment of xerostomia associated with Sjög…

• FDA approval · 2013-02-07
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Supplemental Application (Sandoz Inc)

  FDA approved a supplemental application for pilocarpine hydrochloride submitted by Sandoz Inc, resulting in a labeling update for the produc…

• FDA approval · 2010-06-22
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Original Application (Sandoz Inc)

  FDA approves Sandoz Inc's original application for pilocarpine hydrochloride tablets, establishing a generic option indicated for xerostomia…

• FDA approval · 2007-02-27
  FDA Approved: PILOCARPINE HYDROCHLORIDE — Supplemental Application (AMICI PHARMACEUTICALS LLC)

  The FDA has approved a supplemental application for pilocarpine hydrochloride submitted by Amici Pharmaceuticals LLC, updating the product l…