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 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	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 · 129 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	A078855-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078855-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078855-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	2008-04-17	`84e616aacf4f…`
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…`

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 2 of 2 · 30 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felopdipine	FELODIPINE	A-S Medication Solutions	129c48eb-29f2-462b-ad8a-b3bf1b193115	2024-08-07	Adverse reactions	Name fallback generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	8eadbf3d-c93b-431c-aa86-559fc2a1d5a8	2024-04-03	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Rising Pharma Holdings, Inc.	f5f56c59-04d5-4c5d-9441-5a93d3bdec82	2024-02-17	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Aurobindo Pharma Limited	dd39c559-5c5d-4d3b-9228-c44085e1699f	2024-02-17	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	05feb0a1-8a0c-4d8a-9b86-5e700ea6fd64	2023-12-04	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	A-S Medication Solutions	be3bc927-1ba5-4cdd-9986-64ff29789d7e	2023-11-24	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Westminster Pharmaceuticals, LLC	a6560584-e39f-47b3-84db-95da1f90fd40	2023-04-04	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	30d15f4b-a0ee-4841-ace3-dcaf52016953	2023-03-30	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Bryant Ranch Prepack	196ef773-8a2a-4ef7-a403-2341f94f4d98	2023-03-30	Adverse reactions	Name fallback brand name: Felodipine generic name: FELODIPINE
Felodipine	FELODIPINE	Proficient Rx LP	2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd	2022-04-01	Adverse reactions	Name fallback brand name: Felodipine 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 · 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