Application 019834

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	PLENDIL	FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	PLENDIL	FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
004	PLENDIL	FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No

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

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
N019834-001	PLENDIL	FELODIPINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25
N019834-002	PLENDIL	FELODIPINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25
N019834-004	PLENDIL	FELODIPINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019834-002	PLENDIL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019834-004	PLENDIL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`301d65b070ca…`

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FELODIPINE	FELODIPINE	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	0bef7cf2-012b-4804-ac93-0a8b333035db	2026-08-11	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	924b2633-74bd-469f-b831-77f09dfebbf7	2026-06-23	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	A-S Medication Solutions	e83f5688-55fd-492c-b0d6-e1028d12d618	2026-06-10	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Torrent Pharmaceuticals Limited	60fb803e-ccf7-46f2-b506-e157ce440f87	2026-02-09	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Glenmark Pharmaceuticals Inc., USA	2e4298cf-02e9-49c7-9803-887161e1989a	2026-01-23	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Chartwell RX, LLC	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	2025-12-10	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	57fb4217-00f6-4112-bc63-81fcbe2ea903	2025-11-17	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	2daac7f7-66a8-4be7-b7de-4f1e60bb21f9	2025-04-01	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	b410a9aa-2014-4c25-8a54-2987477650e3	2025-04-01	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	063e633b-03ca-46e2-b6a0-8a300fccee93	2025-04-01	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	ca1c3b54-15a1-4252-938a-0d90f3bec4c5	2025-03-31	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	5c7b7f9a-4f4c-4259-8aae-fdb91ab09eec	2025-03-19	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	782c981d-419a-4fe4-ba44-087731642c78	2025-03-19	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Golden State Medical Supply, Inc.	bdd41c3a-c537-02f3-e053-2995a90a8929	2025-02-24	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Carlsbad Technology, Inc.	7bd4fa00-f0d8-4aea-9c24-a799b05e60e1	2025-02-18	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	b27a13d4-c068-43c8-b654-b8b3276e468a	2024-12-06	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	45e3094c-7755-48c2-be65-c0377f18a400	2024-12-05	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	78341a0a-1274-417e-ae69-e133ee0480f9	2024-11-20	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Endo USA, Inc.	55637724-8757-11de-8a39-0800200c9a66	2024-09-30	Adverse reactions	Name fallback generic name: FELODIPINE
Felopdipine	FELODIPINE	A-S Medication Solutions	129c48eb-29f2-462b-ad8a-b3bf1b193115	2024-08-07	Adverse reactions	Name fallback generic name: FELODIPINE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
63304-435	FELODIPINEEXTENDED-RELEASE TABLETS	felodipine	Ranbaxy Pharmaceuticals Inc	NDA	Current
63304-436	FELODIPINEEXTENDED-RELEASE TABLETS	felodipine	Ranbaxy Pharmaceuticals Inc	NDA	Current
63304-437	FELODIPINEEXTENDED-RELEASE TABLETS	felodipine	Ranbaxy Pharmaceuticals Inc	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
19275	SUPPL	2012-11-05
33998	SUPPL	2012-11-02
41049	SUPPL	2008-08-11
20381	SUPPL	2008-08-11
20379	SUPPL	2008-08-11
41051	SUPPL	2008-08-08
41050	SUPPL	2008-08-08
20383	SUPPL	2008-08-08
20385	SUPPL	2008-08-04
20384	SUPPL	2008-08-04
20382	SUPPL	2008-08-04
41053	SUPPL	2008-04-02
41052	SUPPL	2008-04-02
41048	SUPPL	2008-04-02
11747	SUPPL	2004-06-14
1660	SUPPL	2004-06-14
19274	SUPPL	2004-06-10
11749	SUPPL	2004-06-10
41047	SUPPL	2003-08-07
20380	SUPPL	2003-08-07
11748	SUPPL	2002-05-22
1661	SUPPL	2002-05-22