Application 206788

Type: ANDA
Sponsor: HETERO LABS LTD V

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELTROMBOPAG	ELTROMBOPAG	TABLET;ORAL	12.5MG	No	No
002	ELTROMBOPAG	ELTROMBOPAG	TABLET;ORAL	25MG	No	No
003	ELTROMBOPAG	ELTROMBOPAG	TABLET;ORAL	50MG	No	No
004	ELTROMBOPAG	ELTROMBOPAG	TABLET;ORAL	75MG	No	No

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206788-001	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2025-01-17
A206788-002	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2025-01-17
A206788-003	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2025-01-17
A206788-004	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2025-01-17

Therapeutic equivalence codes#

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

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

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A206788-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2025-01-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206788-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2025-01-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206788-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2025-01-17	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206788-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2025-01-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A206788-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206788-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206788-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A206788-004	AB	1	`a50c72e98297…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ELTROMBOPAG	ELTROMBOPAG	XLCare Pharmaceuticals Inc.	9af1e314-91ca-4ebc-ac12-f9fddc6d7902	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206788 application number: ANDA206788
ELTROMBOPAG	ELTROMBOPAG	Camber Pharmaceuticals, Inc.	e913cd11-f5fb-4ebe-81c7-0c5626b52cfd	2026-06-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206788 application number: ANDA206788

Documents#

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