Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Ipca Laboratories Limited
650387009
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Cerovene, Inc.
Bayshore Pharmaceuticals LLC
Ipca Laboratories Limited
790387927
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chloroquine phosphate
Product Details
NDC Product Code
76385-142Application Number
ANDA090610Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
December 22, 2023HYPROMELLOSESInactive
Code: 3NXW29V3WOClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
POLYETHYLENE GLYCOL 3350Inactive
Code: G2M7P15E5PClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
ChloroquineActive
Code: 6E17K3343PClass: ACTIBQuantity: 250 mg in 1 1