Acetaminophen Overdose

• FDA approval · 2025-07-23
  FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved Cumberland Pharmaceuticals' supplemental application for ACETADOTE (acetylcysteine), updating the product labeling to reflect t…

• FDA approval · 2025-03-14
  FDA Approved: ACETYLCYSTEINE — Original Application (Cameron Pharmaceuticals)

  FDA approves Cameron Pharmaceuticals' Acetylcysteine original application (ANDA 214177). Acetylcysteine is used as a mucolytic and as an ant…

• FDA approval · 2019-10-30
  FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  The FDA approved a supplemental application for Acetadote (acetylcysteine) from Cumberland Pharmaceuticals Inc.

• FDA approval · 2017-01-23
  FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved a supplemental application for Acetadote (acetylcysteine) from Cumberland Pharmaceuticals, resulting in an approved update to t…

• FDA approval · 2016-07-29
  FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  The FDA approved a supplemental application for ACETADOTE (acetylcysteine) from Cumberland Pharmaceuticals, supporting its use as an antidot…

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• FDA approval · 2016-01-10
  FDA Approved: ACETYLCYSTEINE — Supplemental Application (Fresenius Kabi USA, LLC)

  FDA approved a supplemental application for Acetylcysteine from Fresenius Kabi USA, LLC, under an ANDA.

• FDA approval · 2013-01-15
  FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  FDA approved a supplemental application for Acetadote (acetylcysteine) from Cumberland Pharmaceuticals.

• FDA approval · 2008-12-12
  FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)

  The FDA approved Cumberland Pharmaceuticals’ supplemental application for Acetadote (acetylcysteine) under NDA 021539.