Treats oropharyngeal candidiasis (OPC). NDA 22404, held by Galt Pharms. Miconazole.
As of Nov 14, 2026, NDA 22404 (Oravig), held by Galt Pharms, was first approved by FDA on Apr 16, 2010, with 3 approved supplements and 0 published complete response letters.
ORAVIG is indicated for the local treatment of oropharyngeal candidiasis (OPC) in adults.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 16, 2010 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Oravig50MG · tablet;buccal | Miconazole | RxReference drug |
| Feb 4, 2020 | Supplement 5Labeling · Standard review | Approved | |
| Mar 5, 2013 | Supplement 3Labeling · Standard review | Approved | |
| Apr 8, 2011 | Supplement 2Labeling · Standard review | Approved | |
| Apr 16, 2010 | Original applicationNew dosage form · Standard review | Approved |
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
