Atovaquone and Proguanil Hydrochloride

Manufacturing Establishments2

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Glenmark Pharmaceuticals Limited

Labeler

Glenmark Pharmaceuticals Inc.,USA

DUNS Number

862603186

Glenmark Pharmaceuticals Inc.,USA

Labeler

Glenmark Pharmaceuticals Inc.,USA

DUNS Number

079922908

Products2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Product Details

NDC Product Code

68462-404

Application Number

ANDA091211

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

December 31, 2019

Ingredients

POLOXAMER 188Inactive

Code: LQA7B6G8JGClass: IACT

AtovaquoneActive

Code: Y883P1Z2LTClass: ACTIBQuantity: 250 mg in 1 1

ProguanilActive

Code: R71Y86M0WTClass: ACTIBQuantity: 100 mg in 1 1

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive

Code: 2165RE0K14Class: IACT

POVIDONE K30Inactive

Code: U725QWY32XClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

POLYETHYLENE GLYCOL 400Inactive

Code: B697894SGQClass: IACT

POLYETHYLENE GLYCOL 8000Inactive

Code: Q662QK8M3BClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

FERRIC OXIDE REDInactive

Code: 1K09F3G675Class: IACT

HYPROMELLOSE 2910 (15 MPA.S)Inactive

Code: 36SFW2JZ0WClass: IACT

SODIUM STARCH GLYCOLATE TYPE A POTATOInactive

Code: 5856J3G2A2Class: IACT