FDA.reportPublic FDA data

Application 220660

Type
ANDA
Sponsor
AIZANT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINETABLET;ORALEQ 12.5MG ACIDNoNo
002ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINETABLET;ORALEQ 25MG ACIDNoNo
003ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINETABLET;ORALEQ 50MG ACIDNoNo
004ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINETABLET;ORALEQ 75MG ACIDNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A220660-001ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-04-28
A220660-002ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-04-28
A220660-003ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2026-04-28
A220660-004ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-04-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A220660-001AB
A220660-002AB
A220660-003AB
A220660-004AB

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 22:54:322026-06A220660-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-04-28a50c72e98297…
2026-08-01 22:54:322026-06A220660-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-04-28a50c72e98297…
2026-08-01 22:54:322026-06A220660-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2026-04-28a50c72e98297…
2026-08-01 22:54:322026-06A220660-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-04-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A220660-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A220660-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A220660-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A220660-004AB1a50c72e98297…

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 · 9 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Eltrombopag olamineELTROMBOPAG OLAMINEAmerisyn, LLC52ba8e06-aa7d-caa6-e063-6294a90a5ce52026-06-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eltrombopag olamine
generic name: ELTROMBOPAG OLAMINE
Eltrombopag OlamineELTROMBOPAGAvKARE4af8f855-f710-e96f-e063-6294a90abb462026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eltrombopag Olamine
EltrombopagELTROMBOPAG OLAMINEHikma Pharmaceuticals USA Inc.20e91f76-06a8-4ab7-86c7-1df29850b5bd2026-04-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ELTROMBOPAG OLAMINE
eltrombopagELTROMBOPAG OLAMINENovadoz Pharmaceuticals LLC5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ELTROMBOPAG OLAMINE
Eltrombopag olamineELTROMBOPAG OLAMINESomerset Therapeutics, LLC604f663c-4933-402a-8105-5921713cf3c82026-01-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eltrombopag olamine
generic name: ELTROMBOPAG OLAMINE
PROMACTAELTROMBOPAG OLAMINENovartis Pharmaceuticals Corporation7714a0ed-34bb-46e6-a0a5-b363908b22c22025-12-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ELTROMBOPAG OLAMINE
Eltrombopag OlamineELTROMBOPAGAmneal Pharmaceuticals NY LLCc97337c3-d758-40a3-a1ef-fd122f15e8212025-11-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eltrombopag Olamine
Eltrombopag OlamineELTROMBOPAGAmneal Pharmaceuticals NY LLC05acf38e-7870-4809-a045-fc38e66b11102025-09-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eltrombopag Olamine
EltrombopagELTROMBOPAG OLAMINECamber Pharmaceuticals, Inc.8f6499f0-4774-4f1e-8ab5-145c1fe644012025-03-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ELTROMBOPAG OLAMINE