Registrants1
Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.
Natco Pharma Limited
918588174
Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Natco Pharma Limited
Rising Pharmaceuticals, Inc.
Natco Pharma Limited
918588174
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
64980-177Application Number
ANDA091621Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
October 9, 2018ChloroquineActive
Code: 6E17K3343PClass: ACTIBQuantity: 250 mg in 1 1
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92JClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT