FDA
Acetylcysteine
The FDA lists this product in 30 strengths and forms.
Composition
- Active ingredients
- ACETYLCYSTEINE 6GM/30ML (200MG/ML)
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- ACETYLCYSTEINE 6GM/30ML (200MG/ML) · InjectableANDA203624-001 · Tentative approval
- ACETYLCYSTEINE 6GM/30ML (200MG/ML) · InjectableANDA207358-001 · Prescription
- ACETYLCYSTEINE 20% · SolutionANDA219194-002 · Prescription
- ACETYLCYSTEINE 10% · SolutionANDA219194-001 · Prescription
- ACETYLCYSTEINE 20% · SolutionANDA072547-001 · Prescription
- ACETYLCYSTEINE 6GM/30ML (200MG/ML) · InjectableANDA215620-001 · Prescription
- ACETYLCYSTEINE 10% · SolutionANDA072621-001 · Discontinued
- ACETYLCYSTEINE 10% · SolutionANDA214177-001 · Prescription
- ACETYLCYSTEINE 20% · SolutionANDA214177-002 · Prescription
- ACETYLCYSTEINE 10% · SolutionANDA072489-001 · Prescription
- ACETYLCYSTEINE 20% · SolutionANDA203853-001 · Prescription
- ACETYLCYSTEINE 20% · SolutionANDA205643-001 · Discontinued
At a glance
- Brand name
- Acetylcysteine
- Route
- Intravenous
- Dosage form
- Injectable
- Applicant
- Exela Pharma
- Status
- Discontinued
- FDA approval
- 15 Apr 2021
- Application
- ANDA204797-001