Application 211537

Type: ANDA
Sponsor: TORRENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	TABLET;ORAL	10MG;EQ 5MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211537-001	DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE	DAPAGLIFLOZIN; SAXAGLIPTIN HYDROCHLORIDE	10MG;EQ 5MG BASE	TABLET / ORAL	AB		2026-04-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211537-001	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
2026-09-14 22:38:34	2026-08	A211537-001	DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE	10MG;EQ 5MG BASE	TABLET / ORAL	AB	2026-04-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211537-001	DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE	10MG;EQ 5MG BASE	TABLET / ORAL	AB	2026-04-06	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211537-001	DAPAGLIFLOZIN AND SAXAGLIPTIN HYDROCHLORIDE	10MG;EQ 5MG BASE	TABLET / ORAL	AB	2026-04-06	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A211537-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211537-001	AB	1	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211537-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.