FDA.reportPublic FDA data

Application 209938

Type
ANDA
Sponsor
TEVA PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELTROMBOPAGELTROMBOPAGTABLET;ORAL12.5MGNoNo
002ELTROMBOPAGELTROMBOPAGTABLET;ORAL25MGNoNo
003ELTROMBOPAGELTROMBOPAGTABLET;ORAL75MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209938-001ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-07-13
A209938-002ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-07-13
A209938-003ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-07-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A209938-001AB
A209938-002AB
A209938-003AB

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
2026-09-14 22:38:342026-08A209938-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A209938-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-07-1384e616aacf4f…
2026-09-14 22:38:342026-08A209938-003ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-07-1384e616aacf4f…
2026-08-18 06:07:402026-07A209938-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2026-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A209938-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2026-07-13caaa826d4ba7…
2026-08-18 06:07:402026-07A209938-003ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2026-07-13caaa826d4ba7…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A209938-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A209938-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A209938-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A209938-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209938-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A209938-003AB1caaa826d4ba7…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELTROMBOPAGELTROMBOPAGXLCare Pharmaceuticals Inc.9af1e314-91ca-4ebc-ac12-f9fddc6d79022026-07-02Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ELTROMBOPAG
generic name: ELTROMBOPAG
ELTROMBOPAGELTROMBOPAGCamber Pharmaceuticals, Inc.e913cd11-f5fb-4ebe-81c7-0c5626b52cfd2026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ELTROMBOPAG
generic name: ELTROMBOPAG
Eltrombopag OlamineELTROMBOPAGAvKARE4af8f855-f710-e96f-e063-6294a90abb462026-05-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ELTROMBOPAG
eltrombopagELTROMBOPAGDr. Reddy's Laboratories Inc.,e5fd3114-56b8-3ae3-fb03-9820a26ca4c62026-03-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: eltrombopag
generic name: ELTROMBOPAG
ELTROMBOPAGELTROMBOPAGZydus Pharmaceuticals USA Inc.1cfdd1fa-d687-41f9-a160-9491f0beac1e2026-01-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: ELTROMBOPAG
generic name: ELTROMBOPAG
ELTROMBOPAGELTROMBOPAGZydus Lifesciences Limitedae9a7725-64f8-406d-88e7-e6e01136deae2026-01-14Name fallback
brand name: ELTROMBOPAG
generic name: ELTROMBOPAG
eltrombopagELTROMBOPAG OLAMINENovadoz Pharmaceuticals LLC5a9ec8c8-3c0b-4f11-848c-c04ccee0d44f2026-01-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: eltrombopag
ALVAIZELTROMBOPAGTeva Pharmaceuticals, Inc.ed51e463-7a03-4858-bbd2-882ce4753d5a2026-01-01Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ELTROMBOPAG
Eltrombopag OlamineELTROMBOPAGAmneal Pharmaceuticals NY LLCc97337c3-d758-40a3-a1ef-fd122f15e8212025-11-20Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ELTROMBOPAG
Eltrombopag OlamineELTROMBOPAGAmneal Pharmaceuticals NY LLC05acf38e-7870-4809-a045-fc38e66b11102025-09-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: ELTROMBOPAG
EltrombopagELTROMBOPAGBiocon Pharma Inc.074dbfa7-eadb-e722-0a7a-86a97882f0312025-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eltrombopag
generic name: ELTROMBOPAG
EltrombopagELTROMBOPAG OLAMINECamber Pharmaceuticals, Inc.8f6499f0-4774-4f1e-8ab5-145c1fe644012025-03-27Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Eltrombopag

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.