Cerebral Palsy

• FDA approval · 2024-12-06
  FDA Approved: BACLOFEN — Original Application (Advagen Pharma Ltd)

  FDA approved Advagen Pharma Ltd's Baclofen Original Application, confirming a generic Baclofen product for approved indications.

• FDA approval · 2020-08-13
  FDA Approved: BACLOFEN — Supplemental Application (Endo USA, Inc.)

  FDA approved a supplemental application for Baclofen from Endo USA, Inc. (ANDA077068).

• FDA approval · 2019-09-18
  FDA Approved: BACLOFEN — Original Application (Palmetto Pharmaceuticals Inc.)

  FDA records an original application approval for Baclofen submitted by Palmetto Pharmaceuticals Inc. The document marks the approval of a Ba…

• FDA approval · 2019-09-11
  FDA Approved: BACLOFEN (INTRATHECAL) — Original Application (MAIA Pharmaceuticals, Inc.)

  FDA approved an original application for a generic intrathecal baclofen product from MAIA Pharmaceuticals, enabling marketing of intrathecal…

• FDA approval · 2016-12-22
  FDA Approved: LIORESAL (BACLOFEN) — Supplemental Application (Amneal Pharmaceuticals LLC)

  The FDA approved a supplemental application for LIORESAL (baclofen) submitted by Amneal Pharmaceuticals LLC.

• Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
• 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…

• 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 …

• FDA approval · 2009-04-03
  FDA Approved: BACLOFEN — Supplemental Application (Teva Pharmaceuticals USA, Inc.)

  The FDA approved Teva's supplemental application for baclofen (generic), indicating an approval related to the product's labeling or formula…