FDA.reportPublic FDA data

Application 206788

Type
ANDA
Sponsor
HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ELTROMBOPAGELTROMBOPAGTABLET;ORAL12.5MGNoNo
002ELTROMBOPAGELTROMBOPAGTABLET;ORAL25MGNoNo
003ELTROMBOPAGELTROMBOPAGTABLET;ORAL50MGNoNo
004ELTROMBOPAGELTROMBOPAGTABLET;ORAL75MGNoNo

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
A206788-001ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2025-01-17
A206788-002ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2025-01-17
A206788-003ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2025-01-17
A206788-004ELTROMBOPAG OLAMINEELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2025-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206788-001AB
A206788-002AB
A206788-003AB
A206788-004AB

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 06:07:402026-07A206788-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2025-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07A206788-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2025-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07A206788-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2025-01-17caaa826d4ba7…
2026-08-18 06:07:402026-07A206788-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2025-01-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206788-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2025-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206788-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2025-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206788-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2025-01-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206788-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2025-01-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206788-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2025-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206788-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2025-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206788-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2025-01-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206788-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2025-01-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206788-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2025-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206788-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2025-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206788-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2025-01-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206788-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2025-01-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206788-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2025-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206788-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2025-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206788-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2025-01-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206788-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2025-01-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206788-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2025-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206788-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2025-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206788-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2025-01-17b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206788-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2025-01-17b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206788-001ELTROMBOPAG OLAMINEEQ 12.5MG ACIDTABLET / ORALAB2025-01-17a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206788-002ELTROMBOPAG OLAMINEEQ 25MG ACIDTABLET / ORALAB2025-01-17a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206788-003ELTROMBOPAG OLAMINEEQ 50MG ACIDTABLET / ORALAB2025-01-17a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206788-004ELTROMBOPAG OLAMINEEQ 75MG ACIDTABLET / ORALAB2025-01-17a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A206788-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206788-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206788-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A206788-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206788-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206788-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206788-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206788-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206788-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206788-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206788-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206788-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206788-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206788-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206788-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206788-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206788-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206788-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206788-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206788-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206788-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206788-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206788-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206788-004AB1b8a1b40f171c…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206788-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206788-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206788-003AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A206788-004AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206788-001PC2025-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206788-002PC2025-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206788-003PC2025-11-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206788-004PC2025-11-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A206788-001PC2025-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206788-002PC2025-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206788-003PC2025-11-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206788-004PC2025-11-096a471c1ec25d…

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 · 2 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 reactionsExact identifier
application applno (ANDA): 206788
application number: ANDA206788
ELTROMBOPAGELTROMBOPAGCamber Pharmaceuticals, Inc.e913cd11-f5fb-4ebe-81c7-0c5626b52cfd2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206788
application number: ANDA206788

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
81273ORIG 2025-02-19