Treats uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P.…. ANDA 40516, held by Impax Labs. Chloroquine Phosphate.
As of Nov 15, 2026, ANDA 40516 (Chloroquine Phosphate), held by Impax Labs, was first approved by FDA on Aug 29, 2003, with 5 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 |
|---|---|---|---|
| Aug 29, 2003 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chloroquine Phosphate500MG · tablet;oral | Chloroquine Phosphate | Rx |
| Oct 14, 2026 | Supplement 17Labeling · Standard review | Approved | None posted |
| Jul 24, 2023 | Supplement 16Labeling · Standard review | Approved | None posted |
| May 3, 2022 | Supplement 14Labeling · Standard review | Approved | None posted |
| Mar 16, 2022 | Supplement 13Labeling · Standard review | Approved | None posted |
| Apr 28, 2020 | Supplement 11Labeling · Standard review | Approved | None posted |
| Aug 29, 2003 | 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
