For abnormal. ANDA 203853, held by Alvogen. Acetylcysteine.
As of Nov 15, 2026, ANDA 203853 (Acetylcysteine), held by Alvogen, was first approved by FDA on Jun 21, 2012, with 0 approved supplements 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 bronc…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 21, 2012 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetylcysteine20% · solution;inhalation, oral | Acetylcysteine | Rx |
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
