For abnormal. ANDA 214177, held by Conba USA. Acetylcysteine.
As of Nov 15, 2026, ANDA 214177 (Acetylcysteine), held by Conba USA, was first approved by FDA on Mar 14, 2025, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Acetylcysteine solution 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 bronchial w…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Mar 14, 2025 | Original application | Approved | None posted |
| Acetylcysteine10% · solution;inhalation, oral | Acetylcysteine | Rx |
| Acetylcysteine20% · solution;inhalation, oral | Acetylcysteine | Rx |
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