Application 203417

Type: ANDA
Sponsor: AUROBINDO PHARMA 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 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
A203417-001	FELODIPINE	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17
A203417-002	FELODIPINE	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17
A203417-003	FELODIPINE	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203417-001	AB
A203417-002	AB
A203417-003	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	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203417-002	FELODIPINE	5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203417-003	FELODIPINE	10MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203417-001	FELODIPINE	2.5MG	TABLET, EXTENDED RELEASE / ORAL	AB	2013-01-17	`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	A203417-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203417-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203417-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203417-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203417-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203417-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203417-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203417-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203417-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203417-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203417-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203417-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203417-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203417-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203417-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203417-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203417-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203417-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203417-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203417-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203417-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203417-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203417-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203417-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203417-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203417-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203417-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203417-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203417-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203417-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203417-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203417-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203417-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203417-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203417-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203417-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203417-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203417-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203417-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203417-001	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 · 4 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	Exact identifier application applno (ANDA): 203417 application number: ANDA203417 ndc (product): 71335-1318
Felodipine	FELODIPINE	Rising Pharma Holdings, Inc.	f5f56c59-04d5-4c5d-9441-5a93d3bdec82	2024-02-17	Adverse reactions	Exact identifier application applno (ANDA): 203417 application number: ANDA203417 ndc (product): 57237-110 ndc (product): 57237-109 ndc (product): 57237-108
Felodipine	FELODIPINE	Aurobindo Pharma Limited	dd39c559-5c5d-4d3b-9228-c44085e1699f	2024-02-17	Adverse reactions	Exact identifier application applno (ANDA): 203417 application number: ANDA203417 ndc (product): 65862-675 ndc (product): 65862-673 ndc (product): 65862-674
Felodipine	FELODIPINE	A-S Medication Solutions	be3bc927-1ba5-4cdd-9986-64ff29789d7e	2023-11-24	Adverse reactions	Exact identifier application applno (ANDA): 203417 application number: ANDA203417 ndc (product): 50090-5870

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-5870	Felodipine	Felodipine	A-S Medication Solutions	ANDA	Current
57237-108	Felodipine	Felodipine	Rising Health, LLC	ANDA	Current
57237-108	Felodipine	Felodipine	Rising Health, LLC	ANDA	Current
57237-108	Felodipine	Felodipine	Rising Health, LLC	ANDA	Current
57237-109	Felodipine	Felodipine	Rising Health, LLC	ANDA	Current
57237-109	Felodipine	Felodipine	Rising Health, LLC	ANDA	Current
57237-109	Felodipine	Felodipine	Rising Health, LLC	ANDA	Current
57237-110	Felodipine	Felodipine	Rising Health, LLC	ANDA	Current
57237-110	Felodipine	Felodipine	Rising Health, LLC	ANDA	Current
57237-110	Felodipine	Felodipine	Rising Health, LLC	ANDA	Current
65862-673	Felodipine	Felodipine	Aurobindo Pharma Limited	ANDA	Current
65862-673	Felodipine	Felodipine	Aurobindo Pharma Limited	ANDA	Current
65862-673	Felodipine	Felodipine	Aurobindo Pharma Limited	ANDA	Current
65862-674	Felodipine	Felodipine	Aurobindo Pharma Limited	ANDA	Current
65862-674	Felodipine	Felodipine	Aurobindo Pharma Limited	ANDA	Current
65862-674	Felodipine	Felodipine	Aurobindo Pharma Limited	ANDA	Current
65862-675	Felodipine	Felodipine	Aurobindo Pharma Limited	ANDA	Current
65862-675	Felodipine	Felodipine	Aurobindo Pharma Limited	ANDA	Current
65862-675	Felodipine	Felodipine	Aurobindo Pharma Limited	ANDA	Current
71335-1318	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current
71335-1318	Felodipine	Felodipine	Bryant Ranch Prepack	ANDA	Current