FDA.reportPublic FDA data

Application 077399

Type
ANDA
Sponsor
HI TECH PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOCARNITINELEVOCARNITINESOLUTION;ORAL1GM/10MLNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077399-001LEVOCARNITINELEVOCARNITINE1GM/10MLSOLUTION / ORAL2007-10-25

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LEVOCARNITINELEVOCARNITINEBaxter Healthcare Corporation1f38ab0d-ef89-4e92-990f-9da190057e172026-07-02Warnings, Adverse reactionsName fallback
LevocarnitineLEVOCARNITINEANI Pharmaceuticals, Inc.18dc8eae-56c1-46ec-9d21-e17d7b2f91db2025-12-30Warnings, Adverse reactionsName fallback
LevocarnitineLEVOCARNITINEANI Pharmaceuticals, Inc.bfd0d39f-d3b2-4f0d-b7a2-071a545900f42025-12-30Warnings, Adverse reactionsName fallback
levocarnitineLEVOCARNITINEDevatis Inc.79b6182c-ead5-4fdd-bafa-1afbc7a779062025-09-16Warnings, Adverse reactionsName fallback
LevocarnitineLEVOCARNITINERising Pharma Holdings, Inc.ada35959-e317-4161-ae79-3475096c679f2025-07-17Warnings, Adverse reactionsName fallback
LevocarnitineLEVOCARNITINE ORALSaptalis Pharmaceuticals, LLC75b43fb1-4486-48a0-b571-7754dce350a32025-03-18Warnings, Adverse reactionsName fallback
LevocarnitineLEVOCARNITINETRUPHARMA, LLC05ab18c1-fb01-48fa-8f05-0200bb8a5edf2024-12-27Warnings, Adverse reactionsName fallback
LevocarnitineLEVOCARNITINERising Pharma Holdings, Inc.0f749812-8f02-4eeb-91d9-5dd6fc9fa1592024-08-19Warnings, Adverse reactionsName fallback
LevocarnitineLEVOCARNITINEAmerican Regent, Inc.cc4da2c3-f939-444d-9b5b-a57b6051c1902023-06-23Warnings, Adverse reactionsName fallback
LevocarnitineLEVOCARNITINEHikma Pharmaceuticals USA Inc.8f255df8-8a1f-4b4f-ae8c-2c80532ce8d42023-01-06Warnings, Adverse reactionsName fallback

Warnings cross-check#

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warnings

WARNINGS Hypersensitivity Reactions Serious hypersensitivity reactions, including anaphylaxis, laryngeal edema, and bronchospasm have been reported following levocarnitine injection administration, mostly in patients with end stage renal disease who are undergoing dialysis. Some reactions occurred within minutes after intravenous administration of levocarnitine injection. If a severe hypersensitivity reaction occurs, discontinue levocarnitine injection treatment and initiate appropriate medical treatment. Consider the risks and benefits of re-administering levocarnitine injection to individual patients following a severe reaction. If the decision is made to re-administer the product, monitor patients for a reoccurrence of signs and symptoms of a severe hypersensitivity reaction.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Clinical Trials Experience Transient nausea and vomiting have been observed. Less frequent adverse reactions are body odor, nausea, and gastritis. An incidence for these reactions is difficult to estimate due to the confounding effects of the underlying pathology. The table below lists the adverse events that have been reported in two double-blind, placebo- controlled trials in patients on chronic hemodialysis. Events occurring at ≥5% are reported without regard to causality. Adverse Events with a Frequency ≥5% Regardless of Causality by Body System Placebo (n=63) Levocarnitine 10 mg (n=34) Levocarnitine 20 mg (n=62) Levocarnitine 40 mg (n=34) Levocarnitine 10, 20 & 40 mg (n=130) Body as Whole Abdominal pain 17 21 5 6 9 Accidental injury 10 12 8 12 10 Allergic reaction 5 6 2 Asthenia 8 9 8 12 9 Back pain 10 9 8 6 8 Chest pain 14 6 15 12 12 Fever 5 6 5 12 7 Flu syndrome 40 15 27 29 25 Headache 16 12 37 3 22 Infection 17 15 10 24 15 Injection site reaction 59 38 27 38 33 Pain 49 21 32 35 30 Cardiovascular Arrhythmia 5 3 3 2 Atrial fibrillation 2 6 2 Cardiovascular disorder 6 3 5 6 5 Electrocardiogram abnormal 3 6 2 Hemorrhage 6 9 2 3 4 Hypertension 14 18 21 21 20 Hypotension 19 15 19 3 14 Palpitations 3 8 5 Tachycardia 5 6 5 9 6 Vascular disorder 2 2 6 2 Digestive Anorexia 3 3 5 6 5 Constipation 6 3 3 3 3 Diarrhea 19 9 10 35 16 Dyspepsia 10 9 6 5 Gastrointestinal disorder 2 3 6 2 Melena 3 6 2 Nausea 10 9 5 12 8 Stomach atony 5 Vomiting 16 9 16 21 15 Endocrine System Parathyroid disorder 2 6 2 6 4 Hemic/Lymphatic Anemia 3 3 5 12 6 Metabolic/Nutritional Hypercalcemia 3 15 8 6 9 Hyperkalemia 6 6 6 6 6 Hypervolemia 17 3 3 12 5 Peripheral edema 3 6 5 3 5 Weight decrease 3 3 8 3 5 Weight increase 2 3 6 2 Musculo-Skeletal Leg cramps 13 8 4 Myalgia 6 Nervous Anxiety 5 2 1 Depression 3 6 5 6 5 Dizziness 11 18 10 15 13 Drug dependence 2 6 2 Hypertonia 5 3 1 Insomnia 6 3 6 4 Paresthesia 3 3 3 12 5 Vertigo 6 2 Respiratory Bronchitis 5 3 3 Cough increase 16 10 18 9 Dyspnea 19 3 11 3 7 Pharyngitis 33 24 27 15 23 Respiratory disorder 5 Rhinitis 10 6 11 6 9 Sinusitis 5 2 3 2 Skin And Appendages Pruritus 13 8 3 5 Rash 3 5 3 3 Special Senses Amblyopia 2 6 3 Eye disorder 3 6 3 3 Taste perversion 2 9 3 Urogenital Urinary tract infect 6 3 3 2 Kidney failure 5 6 6 6 6 Postmarketing Experience The following adverse reactions have been reported: Neurologic Reacti...

adverse reactions table

Placebo (n=63) Levocarnitine 10 mg (n=34) Levocarnitine 20 mg (n=62) Levocarnitine 40 mg (n=34) Levocarnitine 10, 20 & 40 mg (n=130) Body as Whole Abdominal pain 17 21 5 6 9 Accidental injury 10 12 8 12 10 Allergic reaction 5 6 2 Asthenia 8 9 8 12 9 Back pain 10 9 8 6 8 Chest pain 14 6 15 12 12 Fever 5 6 5 12 7 Flu syndrome 40 15 27 29 25 Headache 16 12 37 3 22 Infection 17 15 10 24 15 Injection site reaction 59 38 27 38 33 Pain 49 21 32 35 30 Cardiovascular Arrhythmia 5