FDA.reportPublic FDA data

Application 211554

Type
ANDA
Sponsor
ZYDUS PHARMS

Application Products#

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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211554-001TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALAB2019-04-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A211554-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A211554-001TRIENTINE HYDROCHLORIDE250MGCAPSULE / ORALAB2019-04-26a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A211554-001AB1a50c72e98297…

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. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 7 matching rows.

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
brand name: Trientine Hydrochloride
generic name: TRIENTINE HYDROCHLORIDE
Trientine HydrochlorideTRIENTINE HYDROCHLORIDENavinta LLC4c9233bd-be3d-46f0-8fa9-a17e61b1b9a82025-02-25Warnings, Adverse reactionsName fallback
brand name: Trientine Hydrochloride
generic name: TRIENTINE HYDROCHLORIDE
Trientine HydrochlorideTRIENTINE HYDROCHLORIDEDr.Reddys Laboratories Incfff41159-af99-94bf-4327-8a6a7ee77b362024-12-19Warnings, Adverse reactionsName fallback
brand name: Trientine Hydrochloride
generic name: TRIENTINE HYDROCHLORIDE
Trientine HydrochlorideTRIENTINE HYDROCHLORIDEPar Health USA, LLC431c7f66-d58b-4eb0-b195-d164788f9acf2024-11-29Warnings, Adverse reactionsName fallback
brand name: Trientine Hydrochloride
generic name: TRIENTINE HYDROCHLORIDE
TRIENTINE HYDROCHLORIDETRIENTINE HYDROCHLORIDECamber Pharmaceuticals, Inc.5240e3de-54b6-4f22-9142-776f0e9ea1d92022-08-02Warnings, Adverse reactionsName fallback
brand name: TRIENTINE HYDROCHLORIDE
generic name: TRIENTINE HYDROCHLORIDE
Trientine hydrochlorideTRIENTINE HYDROCHLORIDENovadoz Pharmaceuticals LLC6bc468ca-07ef-4965-b502-0330b76455a02022-06-15Warnings, Adverse reactionsName fallback
brand name: Trientine hydrochloride
generic name: TRIENTINE HYDROCHLORIDE
SyprineTRIENTINE HYDROCHLORIDEBausch Health US LLCc34f77a7-996b-4470-b5df-d946a7fe5dbe2020-09-01Warnings, Adverse reactionsName fallback
generic name: TRIENTINE HYDROCHLORIDE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
70710-1203Trientine hydrochlorideTrientine hydrochlorideZydus Pharmaceuticals USA Inc.ANDACurrent
70710-1203Trientine hydrochlorideTrientine hydrochlorideZydus Pharmaceuticals (USA) Inc.ANDACurrent
70771-1438Trientine hydrochlorideTrientine hydrochlorideCadila Healthcare LimitedANDACurrent
70771-1438Trientine hydrochlorideTrientine hydrochlorideZydus Lifesciences LimitedANDACurrent
70771-1438Trientine hydrochlorideTrientine hydrochlorideCadila Healthcare LimitedANDACurrent