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 44.

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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2022-10-28 04:53 UTC	2022-10	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020668-001	LEXXEL	5MG;5MG	TABLET, EXTENDED RELEASE / ORAL	1996-12-27	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020668-002	LEXXEL	5MG;2.5MG	TABLET, EXTENDED RELEASE / ORAL	1998-10-28	`a50c72e98297…`

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