For abnormal. ANDA 74037, held by Hospira. Acetylcysteine.
As of Nov 15, 2026, ANDA 74037 (Acetylcysteine), held by Hospira, was first approved by FDA on Aug 30, 1994, with 6 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 |
|---|---|---|---|
| Aug 30, 1994 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acetylcysteine20% · solution;inhalation, oral | Acetylcysteine | Rx |
| Jan 15, 2016 | Supplement 17Labeling · Standard review | Approved | None posted |
| Aug 5, 1998 | Supplement 6Labeling | Approved | None posted |
| Feb 5, 1996 | Supplement 1Manufacturing | Approved | None posted |
| Feb 5, 1996 | Supplement 2Manufacturing | Approved | None posted |
| Feb 5, 1996 | Supplement 3Manufacturing | Approved | None posted |
| Feb 5, 1996 | Supplement 4Labeling | Approved | None posted |
| Aug 30, 1994 | 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
