Application 020668

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LEXXEL	ENALAPRIL MALEATE; FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	5MG;5MG	No	No
002	LEXXEL	ENALAPRIL MALEATE; FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	5MG;2.5MG	No	No

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

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
N020668-001	LEXXEL	ENALAPRIL MALEATE; FELODIPINE	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL			1996-12-27
N020668-002	LEXXEL	ENALAPRIL MALEATE; FELODIPINE	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL			1998-10-28

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
20812	SUPPL	2008-02-19
3051	SUPPL	2007-10-10
41535	SUPPL	2007-07-06
20810	SUPPL	2007-07-06
13177	SUPPL	2005-08-04
3048	SUPPL	2005-08-04
3050	SUPPL	2004-12-29
25483	SUPPL	2004-06-10
13178	SUPPL	2004-06-10
3049	SUPPL	2003-06-22
20811	SUPPL	2002-07-25
35119	SUPPL	1998-10-28
3047	SUPPL	1998-10-28