Application 204800

Type: ANDA
Sponsor: YUNG SHIN PHARM

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	TE codes	Approval date
A204800-001	FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29
A204800-002	FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29
A204800-003	FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A204800-001	AB
A204800-002	AB
A204800-003	AB

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	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204800-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204800-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204800-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-04-29	`1e350fbaab3a…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204800-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204800-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A204800-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204800-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204800-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204800-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204800-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204800-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204800-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204800-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204800-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204800-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204800-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204800-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204800-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204800-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204800-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204800-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204800-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204800-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204800-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204800-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204800-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204800-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204800-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204800-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204800-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204800-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204800-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204800-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204800-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204800-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A204800-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204800-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204800-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204800-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204800-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204800-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204800-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204800-001	AB	1	`1e350fbaab3a…`

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 1 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felodipine	FELODIPINE	Bryant Ranch Prepack	2daac7f7-66a8-4be7-b7de-4f1e60bb21f9	2025-04-01	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800
Felodipine	FELODIPINE	Bryant Ranch Prepack	b410a9aa-2014-4c25-8a54-2987477650e3	2025-04-01	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800
Felodipine	FELODIPINE	Bryant Ranch Prepack	063e633b-03ca-46e2-b6a0-8a300fccee93	2025-04-01	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800
Felodipine	FELODIPINE	Bryant Ranch Prepack	ca1c3b54-15a1-4252-938a-0d90f3bec4c5	2025-03-31	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800 ndc (product): 71335-2175
Felodipine	FELODIPINE	Bryant Ranch Prepack	5c7b7f9a-4f4c-4259-8aae-fdb91ab09eec	2025-03-19	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800 ndc (product): 63629-2017
Felodipine	FELODIPINE	Bryant Ranch Prepack	782c981d-419a-4fe4-ba44-087731642c78	2025-03-19	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800 ndc (product): 63629-2018
Felodipine	FELODIPINE	Golden State Medical Supply, Inc.	bdd41c3a-c537-02f3-e053-2995a90a8929	2025-02-24	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800 ndc (product): 51407-089 ndc (product): 51407-088 ndc (product): 51407-087
Felodipine	FELODIPINE	Carlsbad Technology, Inc.	7bd4fa00-f0d8-4aea-9c24-a799b05e60e1	2025-02-18	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800 ndc (product): 61442-431 ndc (product): 61442-433 ndc (product): 61442-432
Felodipine	FELODIPINE	Bryant Ranch Prepack	78341a0a-1274-417e-ae69-e133ee0480f9	2024-11-20	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800 ndc (product): 63629-2016
Felodipine	FELODIPINE	Proficient Rx LP	2c4dd9a4-61ca-4c88-90f6-12d9e0fdb7cd	2022-04-01	Adverse reactions	Exact identifier application applno (ANDA): 204800 application number: ANDA204800 ndc (product): 71205-922 ndc (product): 71205-920 ndc (product): 71205-921

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
51407-087	Felodipine	Felodipine	Golden State Medical Supply, Inc.	ANDA	Current
51407-087	Felodipine	Felodipine	Golden State Medical Supply, Inc.	ANDA	Current
51407-087	Felodipine	Felodipine	Golden State Medical Supply, Inc.	ANDA	Current
51407-088	Felodipine	Felodipine	Golden State Medical Supply, Inc.	ANDA	Current
51407-088	Felodipine	Felodipine	Golden State Medical Supply, Inc.	ANDA	Current
51407-088	Felodipine	Felodipine	Golden State Medical Supply, Inc.	ANDA	Current
51407-089	Felodipine	Felodipine	Golden State Medical Supply, Inc.	ANDA	Current
51407-089	Felodipine	Felodipine	Golden State Medical Supply, Inc.	ANDA	Current
51407-089	Felodipine	Felodipine	Golden State Medical Supply, Inc.	ANDA	Current
61442-431	Felodipine	Felodipine	Carlsbad Technology, Inc.	ANDA	Current
61442-431	Felodipine	Felodipine	Carlsbad Technology, Inc.	ANDA	Current
61442-431	Felodipine	Felodipine	Carlsbad Technology, Inc.	ANDA	Current
61442-432	Felodipine	Felodipine	Carlsbad Technology, Inc.	ANDA	Current
61442-432	Felodipine	Felodipine	Carlsbad Technology, Inc.	ANDA	Current
61442-432	Felodipine	Felodipine	Carlsbad Technology, Inc.	ANDA	Current
61442-433	Felodipine	Felodipine	Carlsbad Technology, Inc.	ANDA	Current
61442-433	Felodipine	Felodipine	Carlsbad Technology, Inc.	ANDA	Current
61442-433	Felodipine	Felodipine	Carlsbad Technology, Inc.	ANDA	Current
63126-321	FELODIPINE	FELODIPINE	Yung Shin Pharmaceutical Ind. Co., Ltd.	ANDA	Current
63126-322	FELODIPINE	FELODIPINE	Yung Shin Pharmaceutical Ind. Co., Ltd.	ANDA	Current
63126-323	FELODIPINE	FELODIPINE	Yung Shin Pharmaceutical Ind. Co., Ltd.	ANDA	Current
63629-2016	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2016	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2016	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2017	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2017	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2017	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2018	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2018	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2018	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
71205-920	Felodipine	Felodipine	Proficient Rx LP	ANDA	Current
71205-920	Felodipine	Felodipine	Proficient Rx LP	ANDA	Current
71205-921	Felodipine	Felodipine	Proficient Rx LP	ANDA	Current
71205-921	Felodipine	Felodipine	Proficient Rx LP	ANDA	Current
71205-922	Felodipine	Felodipine	Proficient Rx LP	ANDA	Current
71205-922	Felodipine	Felodipine	Proficient Rx LP	ANDA	Current
71335-2175	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current