For abnormal. ANDA 219194, held by Somerset Theraps LLC. Acetylcysteine.
As of Nov 15, 2026, ANDA 219194 (Acetylcysteine), held by Somerset Theraps LLC, was first approved by FDA on Feb 12, 2025, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Acetylcysteine solution, USP is indicated as adjuvant therapy for patients with abnormal, viscid, or inspissated mucous secretions in such conditions as: Chronic bronchopulmonary disease (chronic emphysema, emphysema with bronchitis, chronic asthmatic bronchitis, tuberculosis, bronchiectasis and primary amyloidosis of the lung) Acute bronchopulmonary disease (pneumonia, bronchitis, tracheobronchitis) Pulmonary complications of cystic fibrosis Tracheostomy care Pulmonary complications associated with surgery Use during anesthesia Post-traumatic chest conditions Atelectasis due to mucous obstruction Diagnostic bronchial studies (bronchograms, bronchospirometry, and bronch…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 12, 2025 | Original application | Approved | None posted |
| Acetylcysteine10% · solution;inhalation, oral | Acetylcysteine | Rx |
| Acetylcysteine20% · solution;inhalation, oral | Acetylcysteine | Rx |
| Sep 26, 2025 | Supplement 1Labeling · Standard review | Approved | None posted |
| Feb 12, 2025 | Original application | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
