FDA.reportPublic FDA data

Application 210619

Type
ANDA
Sponsor
AMNEAL PHARMS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDECAPSULE;ORAL250MGNoNo

Orange Book products#

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A210619-001TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDE250MGCAPSULE / ORAL2019-02-08

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
Trientine HydrochlorideTRIENTINE HYDROCHLORIDERising Pharma Holdings, Inc.f33c1322-f7c0-4684-afc8-8caa3f4023dc2025-10-31Warnings, Adverse reactionsName fallback
Trientine HydrochlorideTRIENTINE HYDROCHLORIDENavinta LLC4c9233bd-be3d-46f0-8fa9-a17e61b1b9a82025-02-25Warnings, Adverse reactionsName fallback
Trientine HydrochlorideTRIENTINE HYDROCHLORIDEDr.Reddys Laboratories Incfff41159-af99-94bf-4327-8a6a7ee77b362024-12-19Warnings, Adverse reactionsName fallback
Trientine HydrochlorideTRIENTINE HYDROCHLORIDEPar Health USA, LLC431c7f66-d58b-4eb0-b195-d164788f9acf2024-11-29Warnings, Adverse reactionsName fallback
TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDECamber Pharmaceuticals, Inc.5240e3de-54b6-4f22-9142-776f0e9ea1d92022-08-02Warnings, Adverse reactionsName fallback
Trientine hydrochlorideTRIENTINE HYDROCHLORIDENovadoz Pharmaceuticals LLC6bc468ca-07ef-4965-b502-0330b76455a02022-06-15Warnings, Adverse reactionsName fallback

Warnings cross-check#

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warnings

WARNINGS Patient experience with trientine hydrochloride is limited (see CLINICAL PHARMACOLOGY ). Patients receiving trientine hydrochloride capsules should remain under regular medical supervision throughout the period of drug administration. Patients (especially women) should be closely monitored for evidence of iron deficiency anemia.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS Clinical experience with trientine hydrochloride has been limited. The following adverse reactions have been reported in a clinical study in patients with Wilson's disease who were on therapy with trientine hydrochloride: iron deficiency, systemic lupus erythematosus (see CLINICAL PHARMACOLOGY ). In addition, the following adverse reactions have been reported in marketed use: dystonia, muscular spasm, myasthenia gravis. Trientine hydrochloride is not indicated for treatment of biliary cirrhosis, but in one study of 4 patients treated with trientine hydrochloride for primary biliary cirrhosis, the following adverse reactions were reported: heartburn; epigastric pain and tenderness; thickening, fissuring and flaking of the skin; hypochromic microcytic anemia; acute gastritis; aphthoid ulcers; abdominal pain; melena; anorexia; malaise; cramps; muscle pain; weakness; rhabdomyolysis. A causal relationship of these reactions to drug therapy could not be rejected or established. To report SUSPECTED ADVERSE EVENTS, contact Rising Pharma Holdings, Inc. at 1-844-874-7464 or FDA at 1-800-FDA-1088 or http://www.fda.gov/ for voluntary reporting of adverse reactions.

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
43986-008Trientine HydrochlorideTrientine HydrochlorideBluepharma - Industria Farmaceutica, S.A.ANDACurrent
43986-008Trientine HydrochlorideTrientine HydrochlorideBluepharma - Industria Farmaceutica, S.A.ANDACurrent
43986-008Trientine HydrochlorideTrientine HydrochlorideBluepharma - Industria Farmaceutica, S.A.ANDACurrent
69238-1545Trientine HydrochlorideTrientineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1545Trientine HydrochlorideTrientineAmneal Pharmaceuticals NY LLCANDACurrent
69238-1545Trientine HydrochlorideTrientineAmneal Pharmaceuticals LLCANDACurrent