Application 219121

Type: ANDA
Sponsor: DR REDDYS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	TABLET;ORAL	EQ 12.5MG ACID	No	No
002	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	TABLET;ORAL	EQ 25MG ACID	No	No
003	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	TABLET;ORAL	EQ 50MG ACID	No	No
004	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	TABLET;ORAL	EQ 75MG ACID	No	No
005	ELTROMBOPAG	ELTROMBOPAG	TABLET	25MG	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
A219121-001	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-03-16
A219121-002	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-03-16
A219121-003	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-03-16
A219121-004	ELTROMBOPAG OLAMINE	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-03-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219121-001	AB
A219121-002	AB
A219121-003	AB
A219121-004	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	A219121-001	ELTROMBOPAG OLAMINE	EQ 12.5MG ACID	TABLET / ORAL	AB	2026-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A219121-002	ELTROMBOPAG OLAMINE	EQ 25MG ACID	TABLET / ORAL	AB	2026-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A219121-003	ELTROMBOPAG OLAMINE	EQ 50MG ACID	TABLET / ORAL	AB	2026-03-16	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A219121-004	ELTROMBOPAG OLAMINE	EQ 75MG ACID	TABLET / ORAL	AB	2026-03-16	`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	A219121-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A219121-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A219121-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A219121-004	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
eltrombopag	ELTROMBOPAG	Dr. Reddy's Laboratories Inc.,	e5fd3114-56b8-3ae3-fb03-9820a26ca4c6	2026-03-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219121 application number: ANDA219121