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- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Zydus Lifesciences Limited
Sertraline Hydrochloride
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 NuCare Pharmaceuticals,Inc.
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 Accord Healthcare, Inc.
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 QPharma Inc
- Sertraline hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 NCS HealthCare of KY, LLC dba Vangard Labs
- Sertraline hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Granules Pharmaceuticals Inc.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Advanced Rx Pharmacy of Tennessee, LLC
- Sertraline hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 NCS HealthCare of KY, LLC dba Vangard Labs
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Aurobindo Pharma Limited
- Zoloft SERTRALINE HYDROCHLORIDE 50 mg/1 ROERIG
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 A-S Medication Solutions
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 REMEDYREPACK INC.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 NuCare Pharmaceuticals,Inc.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Pharmasource Meds, LLC
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 A-S Medication Solutions
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 ScieGen Pharmaceuticals Inc
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Bryant Ranch Prepack
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Quallent Pharmaceuticals Health LLC
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 NorthStar Rx LLC
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 Proficient Rx LP
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 Bryant Ranch Prepack
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 St. Mary's Medical Park Pharmacy
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 NuCare Pharmaceuticals,Inc.
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 Bryant Ranch Prepack
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 ScieGen Pharmaceuticals Inc
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 QPharma Inc
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 PD-Rx Pharmaceuticals, Inc.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 REMEDYREPACK INC.
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 Major Pharmaceuticals
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 REMEDYREPACK INC.
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 Lupin Pharmaceuticals, Inc.
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 REMEDYREPACK INC.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Aurobindo Pharma Limited
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 PD-Rx Pharmaceuticals, Inc.
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 Cardinal Health 107, LLC
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 Quality Care Products, LLC
- SERTRALINE SERTRALINE HYDROCHLORIDE 50 mg/1 Exelan Pharmaceuticals, Inc.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Proficient Rx LP
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Northwind Pharmaceuticals
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 PD-Rx Pharmaceuticals, Inc.
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 Quality Care Products, LLC
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 RPK Pharmaceuticals, Inc.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Preferred Pharmaceuticals Inc.
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 REMEDYREPACK INC.
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 Proficient Rx LP
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Denton Pharma, Inc. DBA Northwind Pharmaceuticals
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 RPK Pharmaceuticals, Inc.
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 PD-Rx Pharmaceuticals, Inc.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Zydus Lifesciences Limited
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 REMEDYREPACK INC.
- Zoloft SERTRALINE HYDROCHLORIDE 50 mg/1 ROERIG
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 REMEDYREPACK INC.
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 Lupin Pharmaceuticals, Inc.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 NuCare Pharmaceuticals,Inc.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 A-S Medication Solutions
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 REMEDYREPACK INC.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 REMEDYREPACK INC.
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 Accord Healthcare, Inc.
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 Preferred Pharmaceuticals Inc.
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 NCS HealthCare of KY, LLC dba Vangard Labs
- Sertraline SERTRALINE HYDROCHLORIDE 50 mg/1 Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 Direct Rx
- SERTRALINE HYDROCHLORIDE SERTRALINE HYDROCHLORIDE 50 mg/1 RPK Pharmaceuticals, Inc.
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 NorthStar Rx LLC
- Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE 50 mg/1 A-S Medication Solutions
- Zoloft SERTRALINE HYDROCHLORIDE 50 mg/1 Viatris Specialty LLC
Summary of product characteristics
Effective Time
20230927
Version
6
Spl Product Data Elements
Sertraline Hydrochloride Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE SERTRALINE ALUMINUM OXIDE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM D&C YELLOW NO. 10 FD&C BLUE NO. 2 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE POVIDONE SILICON DIOXIDE TITANIUM DIOXIDE TRIACETIN LIGHT GREEN ROUND Z;82 Sertraline Hydrochloride Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE SERTRALINE SILICON DIOXIDE CROSCARMELLOSE SODIUM FD&C BLUE NO. 1 HYPROMELLOSES LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE TITANIUM DIOXIDE TRIACETIN LIGHT BLUE ROUND Z;81 Sertraline Hydrochloride Sertraline Hydrochloride SERTRALINE HYDROCHLORIDE SERTRALINE SILICON DIOXIDE CROSCARMELLOSE SODIUM HYPROMELLOSES FERRIC OXIDE YELLOW LACTOSE MONOHYDRATE MAGNESIUM STEARATE CELLULOSE, MICROCRYSTALLINE POVIDONE TALC TITANIUM DIOXIDE TRIACETIN YELLOW ROUND Z;80
Application Number
ANDA077106
Brand Name
Sertraline Hydrochloride
Generic Name
Sertraline Hydrochloride
Product Ndc
65841-044
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 65841-043-06 in bottles of 30 tablets Sertraline Hydrochloride Tablets, 25 mg 30 Tablets NDC 65841-044-06 in bottles of 30 tablets Sertraline Hydrochloride Tablets, 50 mg 30 Tablets NDC 65841-045-06 in bottles of 30 tablets Sertraline Hydrochloride Tablets, 100 mg 30 Tablets sertraline tablets 25 mg sertraline tablets 50 mg sertraline tablets 100 mg
Drug section
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