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FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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N019834-001	PLENDIL	FELODIPINE	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25
N019834-002	PLENDIL	FELODIPINE	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25
N019834-004	PLENDIL	FELODIPINE	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1994-09-22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N019834-001	PLENDIL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, EXTENDED RELEASE / ORAL	RLD	1991-07-25	`84e616aacf4f…`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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felodipine	FELODIPINE	Bryant Ranch Prepack	8eadbf3d-c93b-431c-aa86-559fc2a1d5a8	2024-04-03	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Rising Pharma Holdings, Inc.	f5f56c59-04d5-4c5d-9441-5a93d3bdec82	2024-02-17	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Aurobindo Pharma Limited	dd39c559-5c5d-4d3b-9228-c44085e1699f	2024-02-17	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	05feb0a1-8a0c-4d8a-9b86-5e700ea6fd64	2023-12-04	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	A-S Medication Solutions	be3bc927-1ba5-4cdd-9986-64ff29789d7e	2023-11-24	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Westminster Pharmaceuticals, LLC	a6560584-e39f-47b3-84db-95da1f90fd40	2023-04-04	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	30d15f4b-a0ee-4841-ace3-dcaf52016953	2023-03-30	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	196ef773-8a2a-4ef7-a403-2341f94f4d98	2023-03-30	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Proficient Rx LP	2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd	2022-04-01	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