For abnormal. ANDA 72489, held by Am Regent. Acetylcysteine.
As of Nov 15, 2026, ANDA 72489 (Acetylcysteine), held by Am Regent, was first approved by FDA on Jul 28, 1995, with 5 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Acetylcysteine 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 wedge cath…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 28, 1995 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetylcysteine10% · solution;inhalation, oral | Acetylcysteine | Rx |
| Apr 12, 2001 | Supplement 5Manufacturing | Approved | None posted |
| Nov 4, 1999 | Supplement 2Manufacturing | Approved | None posted |
| Jul 30, 1999 | Supplement 4Manufacturing | Approved | None posted |
| Sep 23, 1998 | Supplement 3Labeling | Approved | None posted |
| Mar 13, 1998 | Supplement 1Labeling | Approved | None posted |
| Jul 28, 1995 | 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
