Treats T. vaginalis infection in females and males. NDA 20334, held by Pfizer. Metronidazole.
As of Nov 13, 2026, NDA 20334 (Flagyl), held by Pfizer, was first approved by FDA on May 3, 1995, with 10 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Symptomatic Trichomoniasis. FLAGYL 375 capsules are indicated for the treatment of T. vaginalis infection in females and males when the presence of the trichomonad has been confirmed by appropriate laboratory procedures (wet smears and/or cultures). Asymptomatic Trichomoniasis. FLAGYL 375 capsules are indicated in the treatment of asymptomatic T. vaginalis infection in females when the organism is associated with endocervicitis, cervicitis, or cervical erosion. Since there is evidence that presence of the trichomonad can interfere with accurate assessment of abnormal cytological smears, additional smears should be performed after eradication of the parasite.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 3, 1995 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Flagyl375MG · capsule;oral | Metronidazole | RxReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 8, 2024 | Supplement 15Labeling · Standard review | Approved | |
| Oct 6, 2023 | Supplement 13Labeling · Standard review | Approved | |
| Dec 15, 2021 | Supplement 12Labeling · Standard review | Approved | |
| Mar 5, 2021 | Supplement 11Labeling · Standard review | Approved | |
| Apr 3, 2018 | Supplement 10Labeling · Standard review | Approved | |
| Jul 13, 2015 | Supplement 9Labeling · Standard review | Approved | |
| Aug 16, 2013 | Supplement 8Labeling | Approved | |
| Aug 19, 2010 | Supplement 4Labeling | Approved | |
| Mar 17, 2004 | Supplement 3Labeling · Standard review | Approved | |
| Apr 23, 2003 | Supplement 1Labeling · Standard review | Approved | |
| May 3, 1995 | Original applicationNew formulation or manufacturer · Standard review | 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
