ANDA 207342, held by Amneal Pharms. Guaifenesin.
As of Nov 15, 2026, ANDA 207342 (Guaifenesin), held by Amneal Pharms, was first approved by FDA on Jul 11, 2018, with 1 approved supplement and 0 published complete response letters.
Uses Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and makes coughs more productive.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 11, 2018 | Original application | Approved | None posted |
| Guaifenesin600MG · tablet, extended release;oral | Guaifenesin | OTC |
| Guaifenesin1.2GM · tablet, extended release;oral | Guaifenesin | OTC |
| Nov 3, 2026 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jul 11, 2018 | 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
