Application 219423

Type: NDA
Sponsor: AZURITY

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	WIDAPLIK	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	TABLET;ORAL	EQ 1.25MG BASE;0.625MG;10MG	Yes	No
002	WIDAPLIK	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	TABLET;ORAL	EQ 2.5MG BASE;1.25MG;20MG	Yes	No
003	WIDAPLIK	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	TABLET;ORAL	EQ 5MG BASE;2.5MG;40MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N219423-001	WIDAPLIK	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	EQ 1.25MG BASE;0.625MG;10MG	TABLET / ORAL	RLD	2025-06-05
N219423-002	WIDAPLIK	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	EQ 2.5MG BASE;1.25MG;20MG	TABLET / ORAL	RLD	2025-06-05
N219423-003	WIDAPLIK	AMLODIPINE BESYLATE; INDAPAMIDE; TELMISARTAN	EQ 5MG BASE;2.5MG;40MG	TABLET / ORAL	RLD	2025-06-05

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219423-001	10322117	2038-01-23		Drug product	2025-07-03
N219423-001	12465599	2038-01-23		Drug product	2025-11-18
N219423-002	10799487	2038-01-23	U-3448	Drug product	2025-07-03
N219423-002	12465599	2038-01-23		Drug product	2025-11-18
N219423-003	12673047	2038-01-23		Drug product	2026-07-09

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 3 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219423-001	NP	2028-06-05
N219423-002	NP	2028-06-05
N219423-003	NP	2028-06-05

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219423-001	WIDAPLIK	EQ 1.25MG BASE;0.625MG;10MG	TABLET / ORAL	RLD	2025-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-002	WIDAPLIK	EQ 2.5MG BASE;1.25MG;20MG	TABLET / ORAL	RLD	2025-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-003	WIDAPLIK	EQ 5MG BASE;2.5MG;40MG	TABLET / ORAL	RLD	2025-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-001	WIDAPLIK	EQ 1.25MG BASE;0.625MG;10MG	TABLET / ORAL	RLD	2025-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-002	WIDAPLIK	EQ 2.5MG BASE;1.25MG;20MG	TABLET / ORAL	RLD	2025-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-003	WIDAPLIK	EQ 5MG BASE;2.5MG;40MG	TABLET / ORAL	RLD	2025-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219423-001	WIDAPLIK	EQ 1.25MG BASE;0.625MG;10MG	TABLET / ORAL	RLD	2025-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-002	WIDAPLIK	EQ 2.5MG BASE;1.25MG;20MG	TABLET / ORAL	RLD	2025-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-003	WIDAPLIK	EQ 5MG BASE;2.5MG;40MG	TABLET / ORAL	RLD	2025-06-05	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-001	WIDAPLIK	EQ 1.25MG BASE;0.625MG;10MG	TABLET / ORAL	RLD	2025-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-002	WIDAPLIK	EQ 2.5MG BASE;1.25MG;20MG	TABLET / ORAL	RLD	2025-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-003	WIDAPLIK	EQ 5MG BASE;2.5MG;40MG	TABLET / ORAL	RLD	2025-06-05	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219423-001	10322117	2038-01-23		Drug product	2025-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-001	12465599	2038-01-23		Drug product	2025-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-002	10799487	2038-01-23	U-3448	Drug product	2025-07-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-002	12465599	2038-01-23		Drug product	2025-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-001	10322117	2038-01-23		Drug product	2025-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-001	12465599	2038-01-23		Drug product	2025-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-002	10799487	2038-01-23	U-3448	Drug product	2025-07-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-002	12465599	2038-01-23		Drug product	2025-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219423-001	10322117	2038-01-23		Drug product	2025-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-001	10799487	2038-01-23	U-3448	Drug product	2025-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-002	10322117	2038-01-23		Drug product	2025-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-002	10799487	2038-01-23	U-3448	Drug product	2025-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-003	10322117	2038-01-23		Drug product	2025-07-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-003	10799487	2038-01-23	U-3448	Drug product	2025-07-03	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-001	10322117	2038-01-23		Drug product	2025-07-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-001	12465599	2038-01-23		Drug product	2025-11-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-002	10799487	2038-01-23	U-3448	Drug product	2025-07-03	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-002	12465599	2038-01-23		Drug product	2025-11-18	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-003	12673047	2038-01-23		Drug product	2026-07-09	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219423-001	NP	2028-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-002	NP	2028-06-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219423-003	NP	2028-06-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-001	NP	2028-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-002	NP	2028-06-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219423-003	NP	2028-06-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219423-001	NP	2028-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-002	NP	2028-06-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219423-003	NP	2028-06-05	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-001	NP	2028-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-002	NP	2028-06-05	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219423-003	NP	2028-06-05	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
WIDAPLIK	TELMISARTAN, AMLODIPINE AND INDAPAMIDE	Azurity Pharmaceuticals, Inc.	a30ff81d-420b-40ea-83d8-670260a93fff	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 219423 application number: NDA219423

Documents#

Document, Submission type, Date table
Document	Submission type	Date
82480	ORIG	2025-06-06
82479	ORIG	2025-06-06