Treats uncomplicated malaria due to susceptible strains of P. falciparum, P. malariae, P.…. ANDA 214756, held by Cohance Lifesciences. Chloroquine Phosphate.
As of Nov 15, 2026, ANDA 214756 (Chloroquine Phosphate), held by Cohance Lifesciences, was first approved by FDA on Sep 3, 2021, with 4 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Chloroquine phosphate tablets are indicated for the: Treatment of uncomplicated malaria due to susceptible strains of P. falciparum, P. malariae, P. ovale, and P. vivax. Prophylaxis of malaria in geographic areas where resistance to chloroquine is not present. Treatment of extraintestinal amebiasis. Chloroquine phosphate tablets do not prevent relapses in patients with vivax or ovale malaria because it is not effective against exoerythrocytic forms of the parasites. Limitations of Use in Malaria: Do not use Chloroquine phosphate tablets for the treatment of complicated malaria (high-grade parasitemia and/or complications e.g., cerebral malaria or acute renal failure).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 3, 2021 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chloroquine Phosphate500MG · tablet;oral | Chloroquine Phosphate | Rx |
| Jul 24, 2023 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 10, 2023 | Supplement 3Manufacturing | Approved | None posted |
| May 3, 2022 | Supplement 2Labeling · Standard review | Approved | None posted |
| Mar 17, 2022 | Supplement 1Labeling · Standard review | Approved | None posted |
| Sep 3, 2021 | Original application | 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
