ANDA 208820, held by Ph Health. Praziquantel.
As of Nov 15, 2026, ANDA 208820 (Praziquantel), held by Ph Health, was first approved by FDA on Nov 27, 2017, with 2 approved supplements and 0 published complete response letters.
Praziquantel tablets are indicated in patients aged 1 year and older for the treatment of the following infections: Schistosomiasis due to all species of schistosoma (for example, Schistosoma mekongi, Schistosoma japonicum, Schistosoma mansoni and Schistosoma hematobium ), and Clonorchiasis and Opisthorchiasis due to the liver flukes, Clonorchis sinensis/Opisthorchis viverrini (approval of this indication was based on studies in which the two species were not differentiated) Praziquantel tablets are an anthelmintic indicated in patients aged one year and older for the treatment of the following infections: Schistosomiasis due to all species of schistosoma (for example, Schistosoma mekongi, S…
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 27, 2017 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Praziquantel600MG · tablet;oral | Praziquantel | Rx |
| Aug 22, 2024 | Supplement 3Labeling · Standard review | Approved | None posted |
| Nov 8, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Nov 27, 2017 | Original application | 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
