MedPath
FDA Approval

Sertraline Hydrochloride

Keltman Pharmaceuticals Inc. (DUNS: 362861077)

June 7, 2011

HUMAN PRESCRIPTION DRUG LABEL

Sertraline(50 mg in 1 1)

Manufacturing Establishments (1)

Keltman Pharmaceuticals Inc.

Keltman Pharmaceuticals Inc.

362861077

Products (1)

Sertraline Hydrochloride

68387-119

ANDA077397

ANDA (C73584)

ORAL

June 7, 2011

DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEPClass: IACT
Code: UTI8907Y6XClass: ACTIBQuantity: 50 mg in 1 1
HYDROXYPROPYL CELLULOSEInactive
Code: RFW2ET671PClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2Class: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6Class: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82Class: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8HClass: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQKClass: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQClass: IACT
© Copyright 2025. All Rights Reserved by MedPath