ANDA 217780, held by Pharmazone. Guaifenesin.
As of Nov 15, 2026, ANDA 217780 (Guaifenesin), held by Pharmazone, was first approved by FDA on Aug 21, 2023, with 0 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 |
|---|---|---|---|
| Aug 21, 2023 | Original application | Approved | None posted |
| Guaifenesin600MG · tablet, extended release;oral | Guaifenesin | OTC |
| Guaifenesin1.2GM · tablet, extended release;oral | Guaifenesin | OTC |
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
