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 42.

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
2026-08-18 06:07:402026-07A220660-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07A220660-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07A220660-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2026-04-28caaa826d4ba7…
2026-08-18 06:07:402026-07A220660-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-04-28caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220660-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-04-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220660-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-04-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220660-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2026-04-28a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220660-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-04-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A220660-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A220660-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A220660-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A220660-004AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220660-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220660-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220660-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A220660-004AB1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown 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