Application 219254

Type: ANDA
Sponsor: ZYDUS LIFESCIENCES

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	JAYTHARI	DEFLAZACORT	TABLET;ORAL	6MG	No	No
002	JAYTHARI	DEFLAZACORT	TABLET;ORAL	18MG	No	No
003	JAYTHARI	DEFLAZACORT	TABLET;ORAL	30MG	No	No
004	JAYTHARI	DEFLAZACORT	TABLET;ORAL	36MG	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
A219254-001	JAYTHARI	DEFLAZACORT	6MG	TABLET / ORAL	AB	2025-04-08
A219254-002	JAYTHARI	DEFLAZACORT	18MG	TABLET / ORAL	AB	2025-04-08
A219254-003	JAYTHARI	DEFLAZACORT	30MG	TABLET / ORAL	AB	2025-04-08
A219254-004	JAYTHARI	DEFLAZACORT	36MG	TABLET / ORAL	AB	2025-04-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A219254-001	AB
A219254-002	AB
A219254-003	AB
A219254-004	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
2026-02-19 14:30 UTC	2026-02	A219254-001	JAYTHARI	6MG	TABLET / ORAL	AB	2025-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219254-002	JAYTHARI	18MG	TABLET / ORAL	AB	2025-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219254-003	JAYTHARI	30MG	TABLET / ORAL	AB	2025-04-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219254-004	JAYTHARI	36MG	TABLET / ORAL	AB	2025-04-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-001	JAYTHARI	6MG	TABLET / ORAL	AB	2025-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-002	JAYTHARI	18MG	TABLET / ORAL	AB	2025-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-003	JAYTHARI	30MG	TABLET / ORAL	AB	2025-04-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-004	JAYTHARI	36MG	TABLET / ORAL	AB	2025-04-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219254-001	JAYTHARI	6MG	TABLET / ORAL	AB	2025-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219254-002	JAYTHARI	18MG	TABLET / ORAL	AB	2025-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219254-003	JAYTHARI	30MG	TABLET / ORAL	AB	2025-04-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219254-004	JAYTHARI	36MG	TABLET / ORAL	AB	2025-04-08	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-001	JAYTHARI	6MG	TABLET / ORAL	AB	2025-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-002	JAYTHARI	18MG	TABLET / ORAL	AB	2025-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-003	JAYTHARI	30MG	TABLET / ORAL	AB	2025-04-08	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-004	JAYTHARI	36MG	TABLET / ORAL	AB	2025-04-08	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A219254-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219254-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219254-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A219254-004	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A219254-004	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A219254-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219254-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219254-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A219254-004	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-001	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-002	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-003	AB	1	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A219254-004	AB	1	`a50c72e98297…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Deflazacort	DEFLAZACORT	Zydus Pharmaceuticals (USA) Inc.	f99fde7c-91ac-4d67-bd76-2b18a1d31f7d	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219254 application number: ANDA219254
JAYTHARI	DEFLAZACORT	Zydus Pharmaceuticals (USA) Inc.	ced839ee-1131-45c6-9e38-cc81d85daf1c	2026-07-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219254 application number: ANDA219254
Deflazacort	DEFLAZACORT	AvKARE	459b75a2-3242-3048-e063-6394a90ab882	2025-12-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 219254 application number: ANDA219254