Application 213517

Type: ANDA
Sponsor: I3 PHARMS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RANOLAZINE	RANOLAZINE	TABLET, EXTENDED RELEASE;ORAL	500MG	No	No
002	RANOLAZINE	RANOLAZINE	TABLET, EXTENDED RELEASE;ORAL	1GM	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213517-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2022-04-27
A213517-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2022-04-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A213517-001	AB
A213517-002	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 2 · 58 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	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213517-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213517-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2022-04-27	`9b2671bbb829…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 58 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	A213517-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A213517-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213517-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213517-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213517-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A213517-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213517-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213517-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213517-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213517-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213517-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213517-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213517-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213517-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213517-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213517-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213517-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213517-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213517-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A213517-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213517-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213517-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213517-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213517-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213517-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213517-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213517-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A213517-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213517-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213517-002	AB	1	`5c6f7cd8ea54…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213517-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213517-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213517-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A213517-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213517-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A213517-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213517-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213517-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213517-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213517-002	AB	1	`9b2671bbb829…`

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RANOLAZINE	RANOLAZINE	A2A Integrated Pharmaceuticals	9fb62878-c76a-4be2-99be-962ce2956af2	2025-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213517 application number: ANDA213517
RANOLAZINE	RANOLAZINE	Bryant Ranch Prepack	9199e28a-ddbe-46a4-ab26-9b08034289be	2025-01-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213517 application number: ANDA213517
RANOLAZINE	RANOLAZINE	i3 Pharmaceuticals, LLC	de3185bf-448a-15f7-e053-2995a90a9a2e	2022-05-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213517 application number: ANDA213517 ndc (product): 72319-022 ndc (product): 72319-021

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72319-021	RANOLAZINE	RANOLAZINE	i3 Pharmaceuticals, LLC	ANDA	Current
72319-021	RANOLAZINE	RANOLAZINE	i3 Pharmaceuticals, LLC	ANDA	Current
72319-022	RANOLAZINE	RANOLAZINE	i3 Pharmaceuticals, LLC	ANDA	Current
72319-022	RANOLAZINE	RANOLAZINE	i3 Pharmaceuticals, LLC	ANDA	Current