Application 210847

Type: ANDA
Sponsor: YILING PHARM LTD

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 1.

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
A210847-001	FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26
A210847-002	FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26
A210847-003	FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210847-001	AB
A210847-002	AB
A210847-003	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 · 123 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
2026-02-19 14:30 UTC	2026-02	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210847-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210847-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210847-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2018-10-26	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A210847-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210847-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210847-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210847-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210847-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210847-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210847-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210847-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210847-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210847-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210847-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210847-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210847-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210847-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210847-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210847-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210847-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210847-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210847-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210847-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210847-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210847-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210847-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210847-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210847-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210847-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210847-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210847-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210847-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210847-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210847-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210847-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210847-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210847-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210847-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210847-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210847-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210847-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210847-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210847-001	AB	1	`8072bd15b7f6…`

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Felodipine	FELODIPINE EXTENDED-RELEASE TABLETS	Yiling Pharmaceutical Inc.	7990a581-3e0f-5d8c-e053-2991aa0aa6a7	2025-12-29	Adverse reactions	Exact identifier application applno (ANDA): 210847 application number: ANDA210847 ndc (product): 69117-0030 ndc (product): 69117-0028 ndc (product): 69117-0029
Felodipine	FELODIPINE	Chartwell RX, LLC	fddebfce-70ed-4ee1-8598-bbb8f1ca9263	2025-12-10	Adverse reactions	Exact identifier application applno (ANDA): 210847 application number: ANDA210847
Felopdipine	FELODIPINE	A-S Medication Solutions	129c48eb-29f2-462b-ad8a-b3bf1b193115	2024-08-07	Adverse reactions	Exact identifier application applno (ANDA): 210847 application number: ANDA210847
Felodipine	FELODIPINE	Westminster Pharmaceuticals, LLC	a6560584-e39f-47b3-84db-95da1f90fd40	2023-04-04	Adverse reactions	Exact identifier application applno (ANDA): 210847 application number: ANDA210847

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-4808	Felodipine	Felodipine Extended-release Tablets	A-S Medication Solutions	ANDA	Current
50090-4808	Felodipine	Felodipine Extended-release Tablets	A-S Medication Solutions	ANDA	Current
58657-685	Felodipine	Felodipine	Method Pharmacueticals, LLC	ANDA	Current
58657-685	Felodipine	Felodipine	Method Pharmacueticals, LLC	ANDA	Current
58657-685	Felodipine	Felodipine	Method Pharmacueticals, LLC	ANDA	Current
58657-686	Felodipine	Felodipine	Method Pharmacueticals, LLC	ANDA	Current
58657-686	Felodipine	Felodipine	Method Pharmacueticals, LLC	ANDA	Current
58657-686	Felodipine	Felodipine	Method Pharmacueticals, LLC	ANDA	Current
58657-687	Felodipine	Felodipine	Method Pharmacueticals, LLC	ANDA	Current
58657-687	Felodipine	Felodipine	Method Pharmacueticals, LLC	ANDA	Current
58657-687	Felodipine	Felodipine	Method Pharmacueticals, LLC	ANDA	Current
63629-2320	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2321	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2322	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2323	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2324	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-2325	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
63629-9301	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
69117-0028	Felodipine	Felodipine Extended-release Tablets	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0028	Felodipine	Felodipine Extended-release Tablets	Yiling Pharmaceutical Inc.	ANDA	Current
69117-0028	Felodipine	Felodipine Extended-release Tablets	Yiling Pharmaceutical Inc.	ANDA	Current
69117-0028	Felodipine	Felodipine Extended-release Tablets	Yiling Pharmaceutical Inc.	ANDA	Current
69117-0029	Felodipine	Felodipine Extended-release Tablets	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0029	Felodipine	Felodipine Extended-release Tablets	Yiling Pharmaceutical Inc.	ANDA	Current
69117-0029	Felodipine	Felodipine Extended-release Tablets	Yiling Pharmaceutical Inc.	ANDA	Current
69117-0029	Felodipine	Felodipine Extended-release Tablets	Yiling Pharmaceutical Inc.	ANDA	Current
69117-0030	Felodipine	Felodipine Extended-release Tablets	Yiling Pharmaceutical, Inc.	ANDA	Current
69117-0030	Felodipine	Felodipine Extended-release Tablets	Yiling Pharmaceutical Inc.	ANDA	Current
69117-0030	Felodipine	Felodipine Extended-release Tablets	Yiling Pharmaceutical Inc.	ANDA	Current
69117-0030	Felodipine	Felodipine Extended-release Tablets	Yiling Pharmaceutical Inc.	ANDA	Current