Sialorrhea

• EMA approval · 2025-04-11
  EMA Authorised: Sialanar (glycopyrronium bromide) — Proveca Pharma Limited

  The EMA authorised Sialanar (glycopyrronium bromide) by Proveca Pharma Limited for the treatment of sialorrhea.

• FDA approval · 2023-02-27
  FDA Approved: GLYCOPYRROLATE — Original Application (Lifestar Pharma LLC)

  FDA approves Lifestar Pharma LLC's original ANDA for glycopyrrolate, a generic version of the drug.

• FDA approval · 2021-10-13
  FDA Approved: GLYCOPYRROLATE — Original Application (Nivagen Pharmaceuticals, Inc.)

  FDA approves an original ANDA for a generic glycopyrrolate product from Nivagen Pharmaceuticals.

• FDA approval · 2018-02-23
  FDA Approved: CUVPOSA — Supplemental Application (Merz Pharmaceuticals, LLC)

  FDA approved a supplemental application for CUVPOSA (glycopyrrolate) by Merz Pharmaceuticals, LLC. The action updates the product's labeling…

• FDA approval · 2013-05-21
  FDA Approved: CUVPOSA — Supplemental Application (Merz Pharmaceuticals, LLC)

  The FDA approved a supplemental application for CUVPOSA (glycopyrrolate) by Merz Pharmaceuticals, LLC. This action corresponds to NDA 022571…

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• FDA approval · 2010-07-28
  FDA Approved: CUVPOSA — Original Application (Merz Pharmaceuticals, LLC)

  FDA approved the original application for CUVPOSA (glycopyrrolate) from Merz Pharmaceuticals, LLC, under NDA 022571. It is approved for the …