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- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Zydus Lifesciences Limited
Duloxetine
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Proficient Rx LP
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Proficient Rx LP
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Cardinal Health 107, LLC
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 American Health Packaging
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 BluePoint Laboratories
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Bryant Ranch Prepack
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 REMEDYREPACK INC.
- DULOXETINE DULOXETINE HYDROCHLORIDE 30 mg/1 REMEDYREPACK INC.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 REMEDYREPACK INC.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Major Pharmaceuticals
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Camber Pharmaceuticals, Inc.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Quality Care Products LLC
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 REMEDYREPACK INC.
- Duloxetine HCL DR DULOXETINE HYDROCHLORIDE 30 mg/1 Advanced Rx Pharmacy of Tennessee, LLC
- DRIZALMA SPRINKLE DULOXETINE HYDROCHLORIDE 30 mg/1 SUN PHARMACEUTICAL INDUSTRIES, INC.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Ajanta Pharma USA Inc.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 RPK Pharmaceuticals, Inc.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Preferred Pharmaceuticals Inc.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Aurobindo Pharma Limited
- Duloxetine HCL DR DULOXETINE HYDROCHLORIDE 30 mg/1 Advanced Rx Pharmacy of Tennessee, LLC
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 REMEDYREPACK INC.
- Duloxetine Hydrochloride DULOXETINE HYDROCHLORIDE 30 mg/1 Proficient Rx LP
- Duloxetine Hydrochloride DULOXETINE HYDROCHLORIDE 30 mg/1 Apotex Corp.
- Duloxetine Hydrochloride DULOXETINE HYDROCHLORIDE 30 mg/1 Macleods Pharmaceuticals Limited
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 PD-Rx Pharmaceuticals, Inc.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Ajanta Pharma USA Inc.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Proficient Rx LP
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Cardinal Health 107, LLC
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Bryant Ranch Prepack
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 ST. MARY'S MEDICAL PARK PHARMACY
- Cymbalta DULOXETINE HYDROCHLORIDE 30 mg/1 Eli Lilly and Company
- Duloxetine Hydrochloride DULOXETINE HYDROCHLORIDE 30 mg/1 Macleods Pharmaceuticals Limited
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Zydus Lifesciences Limited
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Zydus Pharmaceuticals USA Inc.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 REMEDYREPACK INC.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 MARKSANS PHARMA LIMITED
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 REMEDYREPACK INC.
- Duloxetine Hydrochloride DULOXETINE HYDROCHLORIDE 30 mg/1 Macleods Pharmaceuticals Limited
- _ DULOXETINE HYDROCHLORIDE 30 mg/1 Qingdao BAHEAL Pharmaceutical Co., Ltd.
- Duloxetine hydrochloride DULOXETINE HYDROCHLORIDE 30 mg/1 NCS HealthCare of KY, LLC dba Vangard Labs
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Zydus Pharmaceuticals (USA) Inc.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Sun Pharmaceutical Industries, Inc.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Camber Pharmaceuticals, Inc.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Inventia Healthcare Private Limited
- DULOXETINE DULOXETINE HYDROCHLORIDE 30 mg/1 REMEDYREPACK INC.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Aurobindo Pharma Limited
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 BluePoint Laboratories
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 St. Mary's Medical Park Pharmacy
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Asclemed USA, Inc.
- _ DULOXETINE HYDROCHLORIDE 30 mg/1 Qingdao BAHEAL Pharmaceutical Co., Ltd.
- Cymbalta DULOXETINE HYDROCHLORIDE 30 mg/1 Eli Lilly and Company
- DULOXETINE HYDROCHLORIDE DULOXETINE HYDROCHLORIDE 30 mg/1 Alembic Pharmaceuticals Limited
- Duloxetine hydrochloride DULOXETINE HYDROCHLORIDE 30 mg/1 Torrent Pharmaceuticals Limited
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Aphena Pharma Solutions - Tennessee, LLC
- DULOXETINE DULOXETINE HYDROCHLORIDE 30 mg/1 Solco Healthcare US, LLC
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 BluePoint
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Zydus Lifesciences Limited
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Ascend Laboratories, LLC
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Lupin Pharmaceuticals, Inc.
- Duloxetine DULOXETINE HYDROCHLORIDE 30 mg/1 Rising Pharma Holdings, Inc.
Summary of product characteristics
Effective Time
20230921
Version
5
Spl Product Data Elements
Duloxetine Duloxetine DULOXETINE HYDROCHLORIDE DULOXETINE ALCOHOL AMMONIA BUTYL ALCOHOL D&C YELLOW NO. 10 FD&C BLUE NO. 1 FD&C YELLOW NO. 6 FERRIC OXIDE YELLOW GELATIN HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) HYPROMELLOSES ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC SODIUM LAURYL SULFATE STARCH, CORN SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE GREEN WHITE CAPSULE 385;20;mg Duloxetine Duloxetine DULOXETINE HYDROCHLORIDE DULOXETINE FD&C BLUE NO. 1 GELATIN HYPROMELLOSES HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE D&C YELLOW NO. 10 FD&C RED NO. 40 FD&C YELLOW NO. 6 BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC AMMONIA FERRIC OXIDE YELLOW STARCH, CORN BLUE GREEN CAPSULE 386;30;mg Duloxetine Duloxetine DULOXETINE HYDROCHLORIDE DULOXETINE FD&C BLUE NO. 1 GELATIN HYPROMELLOSES HYPROMELLOSE PHTHALATE (31% PHTHALATE, 40 CST) SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE TRIETHYL CITRATE FD&C RED NO. 40 BUTYL ALCOHOL ALCOHOL ISOPROPYL ALCOHOL PROPYLENE GLYCOL SHELLAC AMMONIA FERRIC OXIDE YELLOW STARCH, CORN BLUE WHITE CAPSULE 387;60;mg
Application Number
ANDA090728
Brand Name
Duloxetine
Generic Name
Duloxetine
Product Ndc
70771-1345
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Package Label Principal Display Panel
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL NDC 70771-1344-3 Duloxetine Delayed-release Capsules, 20mg 30 Capsules Rx only NDC 70771-1345-3 Duloxetine Delayed-release Capsules, 30mg 30 Capsules Rx only NDC 70771-1346-3 Duloxetine Delayed-release Capsules, 60mg 30 Capsules Rx only Duloxetine delayed-release capsules Duloxetine delayed-release capsules Duloxetine delayed-release capsules
Spl Medguide
Manufactured by: Cadila Healthcare Ltd. India.
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