Application 216842

Type: ANDA
Sponsor: HIKMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ERTUGLIFLOZIN	ERTUGLIFLOZIN	TABLET;ORAL	5MG	No	No
002	ERTUGLIFLOZIN	ERTUGLIFLOZIN	TABLET;ORAL	15MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A216842-001	ERTUGLIFLOZIN	ERTUGLIFLOZIN	5MG	TABLET / ORAL			2025-01-21
A216842-002	ERTUGLIFLOZIN	ERTUGLIFLOZIN	15MG	TABLET / ORAL			2025-01-21

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	A216842-001	ERTUGLIFLOZIN	5MG	TABLET / ORAL		2025-01-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216842-002	ERTUGLIFLOZIN	15MG	TABLET / ORAL		2025-01-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216842-001	ERTUGLIFLOZIN	5MG	TABLET / ORAL		2025-01-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216842-002	ERTUGLIFLOZIN	15MG	TABLET / ORAL		2025-01-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216842-001	ERTUGLIFLOZIN	5MG	TABLET / ORAL		2025-01-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216842-002	ERTUGLIFLOZIN	15MG	TABLET / ORAL		2025-01-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216842-001	ERTUGLIFLOZIN	5MG	TABLET / ORAL		2025-01-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216842-002	ERTUGLIFLOZIN	15MG	TABLET / ORAL		2025-01-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216842-001	ERTUGLIFLOZIN	5MG	TABLET / ORAL	AB	2025-01-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216842-002	ERTUGLIFLOZIN	15MG	TABLET / ORAL	AB	2025-01-21	`b8a1b40f171c…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216842-001	ERTUGLIFLOZIN	5MG	TABLET / ORAL		2025-01-21	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A216842-002	ERTUGLIFLOZIN	15MG	TABLET / ORAL		2025-01-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216842-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216842-002	AB	1	`b8a1b40f171c…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
STEGLATRO	ERTUGLIFLOZIN	Merck Sharp & Dohme LLC	e6f3e718-bb99-48f1-ab94-b9f0af05fed6	2026-06-03	Warnings, Adverse reactions	Name fallback generic name: ERTUGLIFLOZIN

Documents#

Document, Submission type, Date table
Document	Submission type	Date
74146	ORIG	2023-05-02