Acetaminophen Overdose
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Sign up freeTop drugs studied for this disease
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CLINICAL_TRIALS research · 2026-03-06Clinical Trial Update: Evaluation of Differences Between the Standered NAC Regimen Protocol and the SNAP Regimen Protocol in the Treatment of Paracetamol Toxicity for Cases Presented Early and Late to Assiut University Hospitals in Terms of Safety and Efficiecy. [NA]
A clinical trial evaluating differences between the standard N-acetylcysteine regimen and a SNAP regimen for acetaminophen overdose, assessi…
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CLINICAL_TRIALS trial_result · 2025-11-25Clinical Trial Update: Evaluation of the Efficacy of Fomepizole in the Treatment of Acetaminophen Overdose [Phase 2]
A Phase 2 trial evaluating fomepizole for acetaminophen overdose was terminated; no efficacy results are reported.
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FDA approval · 2025-07-23FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)
FDA approved Cumberland Pharmaceuticals' supplemental application for ACETADOTE (acetylcysteine), updating the product labeling to reflect t…
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FDA approval · 2025-03-14FDA 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…
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FDA label_change · 2021-09-27FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)
FDA approved a supplemental application for Acetadote (acetylcysteine) from Cumberland Pharmaceuticals, likely resulting in changes to the p…
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FDA approval · 2019-10-30FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)
The FDA approved a supplemental application for Acetadote (acetylcysteine) from Cumberland Pharmaceuticals Inc.
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FDA approval · 2017-01-23FDA 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…
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FDA approval · 2016-07-29FDA 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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CLINICAL_TRIALS trial_result · 2016-03-03Clinical Trial Update: Acute Acetaminophen Ingestion: Does Repeated Acetaminophen Blood Test Have an Interest?
This clinical trial evaluated repeated acetaminophen blood testing after acute overdose, but the study has been terminated.
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FDA approval · 2016-01-10FDA Approved: ACETYLCYSTEINE — Supplemental Application (Fresenius Kabi USA, LLC)
FDA approved a supplemental application for Acetylcysteine from Fresenius Kabi USA, LLC, under an ANDA.
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CLINICAL_TRIALS trial_result · 2014-08-04Clinical Trial Update: Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection [Phase 3]
A Phase 3 trial evaluating a new formulation of acetylcysteine injection for acetaminophen overdose was terminated with results posted in 20…
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FDA label_change · 2013-06-05FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)
The FDA approved Cumberland Pharmaceuticals' supplemental application for Acetadote (acetylcysteine), updating the product labeling.
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FDA approval · 2013-01-15FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)
FDA approved a supplemental application for Acetadote (acetylcysteine) from Cumberland Pharmaceuticals.
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FDA approval · 2008-12-12FDA Approved: ACETADOTE — Supplemental Application (Cumberland Pharmaceuticals Inc.)
The FDA approved Cumberland Pharmaceuticals’ supplemental application for Acetadote (acetylcysteine) under NDA 021539.