Application 022314

Type: NDA
Sponsor: NOVARTIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;12.5MG;160MG	Yes	No
002	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 5MG BASE;25MG;160MG	Yes	No
003	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;12.5MG;160MG	Yes	No
004	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;160MG	Yes	No
005	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	TABLET;ORAL	EQ 10MG BASE;25MG;320MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022314-001	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30
N022314-002	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30
N022314-003	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30
N022314-004	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30
N022314-005	EXFORGE HCT	AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-product	TE code
N022314-001	AB
N022314-002	AB
N022314-003	AB
N022314-004	AB
N022314-005	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.

Product history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022314-001	EXFORGE HCT	EQ 5MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022314-002	EXFORGE HCT	EQ 5MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022314-003	EXFORGE HCT	EQ 10MG BASE;12.5MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022314-004	EXFORGE HCT	EQ 10MG BASE;25MG;160MG	TABLET / ORAL	AB	RLD	2009-04-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022314-005	EXFORGE HCT	EQ 10MG BASE;25MG;320MG	TABLET / ORAL	AB	RLD, RS	2009-04-30	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 210 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022314-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N022314-005	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022314-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022314-005	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022314-005	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022314-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022314-005	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022314-005	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022314-005	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022314-005	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022314-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022314-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022314-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022314-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022314-005	AB	1	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 9 · 360 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Submission date	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-001	8101599	2023-05-16	Drug product	2012-01-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-001	8475839	2023-05-16	Drug product	2013-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-001	8475839*PED	2023-11-16	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-002	8101599	2023-05-16	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-002	8475839	2023-05-16	Drug product	2013-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-002	8475839*PED	2023-11-16	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-003	8101599	2023-05-16	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-003	8475839	2023-05-16	Drug product	2013-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-003	8475839*PED	2023-11-16	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-004	8101599	2023-05-16	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-004	8475839	2023-05-16	Drug product	2013-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-004	8475839*PED	2023-11-16	Pediatric extension		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-005	8101599	2023-05-16	Drug product		`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-005	8475839	2023-05-16	Drug product	2013-08-01	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022314-005	8475839*PED	2023-11-16	Pediatric extension		`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022314-001	8101599	2023-05-16	Drug product	2012-01-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-001	8475839	2023-05-16	Drug product	2013-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-001	8475839*PED	2023-11-16	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-002	8101599	2023-05-16	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-002	8475839	2023-05-16	Drug product	2013-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-002	8475839*PED	2023-11-16	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-003	8101599	2023-05-16	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-003	8475839	2023-05-16	Drug product	2013-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-003	8475839*PED	2023-11-16	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-004	8101599	2023-05-16	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-004	8475839	2023-05-16	Drug product	2013-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-004	8475839*PED	2023-11-16	Pediatric extension		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-005	8101599	2023-05-16	Drug product		`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-005	8475839	2023-05-16	Drug product	2013-08-01	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N022314-005	8475839*PED	2023-11-16	Pediatric extension		`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022314-001	8101599	2023-05-16	Drug product	2012-01-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-001	8475839	2023-05-16	Drug product	2013-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-001	8475839*PED	2023-11-16	Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-002	8101599	2023-05-16	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-002	8475839	2023-05-16	Drug product	2013-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-002	8475839*PED	2023-11-16	Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-003	8101599	2023-05-16	Drug product		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-003	8475839	2023-05-16	Drug product	2013-08-01	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-003	8475839*PED	2023-11-16	Pediatric extension		`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N022314-004	8101599	2023-05-16	Drug product		`4b0b4de00fa7…`

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
Exforge HCT	AMLODIPINE VALSARTAN AND HYDROCHLOROTHIAZIDE	Novartis Pharmaceuticals Corporation	18d7820d-471f-4ee2-9ec6-25d8d27c77de	2025-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022314 application number: NDA022314 ndc (product): 0078-0563 ndc (product): 0078-0561 ndc (product): 0078-0562 ndc (product): 0078-0559 ndc (product): 0078-0560

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 50 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0559	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0560	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0561	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0562	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0078-0563	Exforge HCT	amlodipine valsartan and hydrochlorothiazide	Novartis Pharmaceuticals Corporation	NDA	Current
0781-5756	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5760	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5771	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5787	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current
0781-5794	AMLODIPINE, VALSARTAN, HYDROCHLOROTHIAZIDE	amlodipine valsartan and hydrochlorothiazide	Sandoz Inc	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72400	SUPPL	2022-10-17
72311	SUPPL	2022-10-12
67995	SUPPL	2021-06-30
66321	SUPPL	2021-02-23
64380	SUPPL	2020-08-24
64336	SUPPL	2020-08-20
59063	SUPPL	2019-06-13
59060	SUPPL	2019-06-13
17233	SUPPL	2015-07-30
7222	SUPPL	2015-07-30
38560	SUPPL	2014-09-26
29582	SUPPL	2014-09-25
38559	SUPPL	2014-06-10
38558	SUPPL	2014-03-19
38557	SUPPL	2014-03-19
29581	SUPPL	2014-03-19
7221	SUPPL	2014-03-19
17232	SUPPL	2012-12-10
29580	SUPPL	2012-11-29
29579	SUPPL	2012-10-02
17231	SUPPL	2012-10-01
29576	SUPPL	2012-02-21
17229	SUPPL	2012-02-17
29578	SUPPL	2012-01-20
7220	SUPPL	2011-12-14
38556	SUPPL	2011-12-13
29577	SUPPL	2011-11-02
17230	SUPPL	2011-10-31
17228	SUPPL	2011-06-27
29575	SUPPL	2011-06-13
42489	ORIG	2009-09-02
24280	ORIG	2009-09-02
29574	ORIG	2009-05-14
17227	ORIG	2009-05-11