Manufacturing Establishments (1)
Lake Erie Medical DBA Quality Care Products LLC
Lake Erie Medical DBA Quality Care Products LLC
831276758
Products (1)
ESOMEPRAZOLE MAGNESIUM
55700-428
ANDA203636
ANDA (C73584)
ORAL
January 2, 2019
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
SUCROSEInactive
Code: C151H8M554Class: IACT
TRIETHYL CITRATEInactive
Code: 8Z96QXD6UMClass: IACT
GELATINInactive
Code: 2G86QN327LClass: IACT
GLYCERYL MONOSTEARATEInactive
Code: 230OU9XXE4Class: IACT
GLYCERYL STEARATE SEInactive
Code: FCZ5MH785IClass: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71GClass: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4TClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
TALCInactive
Code: 7SEV7J4R1UClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
METHACRYLIC ACIDInactive
Code: 1CS02G8656Class: IACT
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive
Code: NX76LV5T8JClass: IACT
POVIDONEInactive
Code: FZ989GH94EClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
SHELLACInactive
Code: 46N107B71OClass: IACT
POVIDONE K90Inactive
Code: RDH86HJV5ZClass: IACT
EsomeprazoleActive
Code: R6DXU4WAY9Class: ACTIMQuantity: 40 mg in 1 1
ETHYLCELLULOSESInactive
Code: 7Z8S9VYZ4BClass: IACT