ANDA 209254, held by Ohm Labs Inc. Guaifenesin.
As of Nov 15, 2026, ANDA 209254 (Guaifenesin), held by Ohm Labs Inc, was first approved by FDA on Jul 16, 2018, 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 |
|---|---|---|---|
| Jul 16, 2018 | 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
