Application 078855

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	FELODIPINE	FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	2.5MG	No	No
002	FELODIPINE	FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	5MG	No	No
003	FELODIPINE	FELODIPINE	TABLET, EXTENDED RELEASE;ORAL	10MG	No	No

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

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	Approval date
A078855-001	FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17
A078855-002	FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17
A078855-003	FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-09-15 20:21 UTC	2019-09	A078855-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078855-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A078855-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078855-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078855-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A078855-003	AB	1	`ea99ee380514…`

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 · 30 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 brand name: FELODIPINE generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	924b2633-74bd-469f-b831-77f09dfebbf7	2026-06-23	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	A-S Medication Solutions	e83f5688-55fd-492c-b0d6-e1028d12d618	2026-06-10	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Torrent Pharmaceuticals Limited	60fb803e-ccf7-46f2-b506-e157ce440f87	2026-02-09	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Glenmark Pharmaceuticals Inc., USA	2e4298cf-02e9-49c7-9803-887161e1989a	2026-01-23	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE EXTENDED-RELEASE TABLETS	Yiling Pharmaceutical Inc.	7990a581-3e0f-5d8c-e053-2991aa0aa6a7	2025-12-29	Adverse reactions	Name fallback brand name: Felodipine
Felodipine	FELODIPINE	Chartwell RX, LLC	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	2025-12-10	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	57fb4217-00f6-4112-bc63-81fcbe2ea903	2025-11-17	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	2daac7f7-66a8-4be7-b7de-4f1e60bb21f9	2025-04-01	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	b410a9aa-2014-4c25-8a54-2987477650e3	2025-04-01	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	063e633b-03ca-46e2-b6a0-8a300fccee93	2025-04-01	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	ca1c3b54-15a1-4252-938a-0d90f3bec4c5	2025-03-31	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	5c7b7f9a-4f4c-4259-8aae-fdb91ab09eec	2025-03-19	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	782c981d-419a-4fe4-ba44-087731642c78	2025-03-19	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Golden State Medical Supply, Inc.	bdd41c3a-c537-02f3-e053-2995a90a8929	2025-02-24	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Carlsbad Technology, Inc.	7bd4fa00-f0d8-4aea-9c24-a799b05e60e1	2025-02-18	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	b27a13d4-c068-43c8-b654-b8b3276e468a	2024-12-06	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	45e3094c-7755-48c2-be65-c0377f18a400	2024-12-05	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	78341a0a-1274-417e-ae69-e133ee0480f9	2024-11-20	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Endo USA, Inc.	55637724-8757-11de-8a39-0800200c9a66	2024-09-30	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-5011	Felodipine	Felodipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5012	Felodipine	Felodipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-5013	Felodipine	Felodipine	Mylan Pharmaceuticals Inc.	ANDA	Current
0615-6572	Felodipine	Felodipine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
0615-6573	Felodipine	Felodipine	NCS HealthCare of KY, Inc dba Vangard Labs	ANDA	Current
51079-467	Felodipine	Felodipine	Mylan Institutional Inc.	ANDA	Current