Treats uncomplicated malaria due to susceptible strains of P. falciparum, P.malariae, P.…. ANDA 91621, held by Natco Pharma Ltd. Chloroquine Phosphate.
As of Nov 15, 2026, ANDA 91621 (Chloroquine Phosphate), held by Natco Pharma Ltd, was first approved by FDA on Jan 21, 2011, 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 |
|---|---|---|---|
| Jan 21, 2011 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Chloroquine Phosphate250MG · tablet;oral | Chloroquine Phosphate | Rx |
| Jul 24, 2023 | Supplement 6Labeling · Standard review | Approved | None posted |
| May 3, 2022 | Supplement 5Labeling · Standard review | Approved | None posted |
| Mar 21, 2022 | Supplement 4Labeling · Standard review | Approved | None posted |
| Mar 21, 2022 | Supplement 3Labeling · Standard review | Approved | None posted |
| Jan 21, 2011 | 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
