ESOMEPRAZOLE MAGNESIUM

Registrants (1)

Torrent Pharma, Inc.

DUNS Number

790033935

Manufacturing Establishments (1)

Torrent Pharmaceuticals Limited

Labeler

Torrent Pharmaceuticals Limited

Registrant

Torrent Pharma, Inc.

DUNS Number

916488547

Products (2)

NDC Product Code

13668-155

Application Number

ANDA203636

Marketing Category

ANDA (C73584)

Route of Administration

ORAL

Effective Date

October 6, 2023

Ingredients

ETHYLCELLULOSESInactive

Code: 7Z8S9VYZ4BClass: IACT

GLYCERYL MONOSTEARATEInactive

Code: 230OU9XXE4Class: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

GELATINInactive

Code: 2G86QN327LClass: IACT

MAGNESIUM OXIDEInactive

Code: 3A3U0GI71GClass: IACT

GLYCERYL STEARATE SEInactive

Code: FCZ5MH785IClass: IACT

METHACRYLIC ACIDInactive

Code: 1CS02G8656Class: IACT

METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE AInactive

Code: NX76LV5T8JClass: IACT

POLYSORBATE 80Inactive

Code: 6OZP39ZG8HClass: IACT

POVIDONEInactive

Code: FZ989GH94EClass: IACT

POTASSIUM HYDROXIDEInactive

Code: WZH3C48M4TClass: IACT

POVIDONE K90Inactive

Code: RDH86HJV5ZClass: IACT

PROPYLENE GLYCOLInactive

Code: 6DC9Q167V3Class: IACT

SHELLACInactive

Code: 46N107B71OClass: IACT

SODIUM HYDROXIDEInactive

Code: 55X04QC32IClass: IACT

TITANIUM DIOXIDEInactive

Code: 15FIX9V2JPClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

EsomeprazoleActive

Code: R6DXU4WAY9Class: ACTIMQuantity: 40 mg in 1 1

TALCInactive

Code: 7SEV7J4R1UClass: IACT

TRIETHYL CITRATEInactive

Code: 8Z96QXD6UMClass: IACT