ANDA 213420, held by Granules. Guaifenesin.
As of Nov 15, 2026, ANDA 213420 (Guaifenesin), held by Granules, was first approved by FDA on May 8, 2020, with 2 approved supplements and 0 published complete response letters.
Uses ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 8, 2020 | Original application | Approved | None posted |
| Guaifenesin600MG · tablet, extended release;oral | Guaifenesin | OTC |
| Guaifenesin1.2GM · tablet, extended release;oral | Guaifenesin | OTC |
| Nov 3, 2026 | Supplement 10Labeling · Standard review | Approved | None posted |
| Dec 9, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| May 8, 2020 | 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
