General MedicationsINHALATION, ORALStandard
ACETYLCYSTEINE
ACETYLCYSTEINE
Standard Dose
20%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview ACETYLCYSTEINE is listed in Drugs@FDA under application 219194 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient ACETYLCYSTEINE Form and strength SOLUTION;INHALATION, ORAL - 20% Sponsor SOMERSET THERAPS LLC Submission history Latest submission status date: 2025-09-26 00:00:00.
Structured Monograph
Clinical summary
Approval overview ACETYLCYSTEINE is listed in Drugs@FDA under application 219194 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient ACETYLCYSTEINE Form and strength SOLUTION;INHALATION, ORAL - 20% Sponsor SOMERSET THERAPS LLC Submission history Latest submission status date: 2025-09-26 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.