Application 210482

Type: ANDA
Sponsor: ANI PHARMS INC

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 43.

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
A210482-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL			2019-10-29
A210482-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL			2019-10-29

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 3 · 82 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
2026-09-14 22:38:34	2026-08	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL		2019-10-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210482-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210482-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-10-29	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A210482-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210482-002	AB	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A210482-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A210482-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210482-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A210482-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210482-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A210482-002	AB	1	`3f01610625f2…`

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 · 31 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RANOLAZINE	RANOLAZINE	ScieGen Pharmaceuticals, Inc	71d50258-75b7-4801-b0f4-c34fe883d57d	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: RANOLAZINE generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Proficient Rx LP	c7ed8234-e6bd-4f19-a1ce-40f272a79036	2024-07-01	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Aphena Pharma Solutions - Tennessee, LLC	abb32182-46ba-49d2-b2ac-13de2ecf802d	2024-04-02	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Aurobindo Pharma Limited	49873158-5c0a-41da-86a2-369ef6b0cbc8	2024-02-15	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
RANOLAZINE	RANOLAZINE	Lupin Pharmaceuticals, Inc.	595821d7-1fbf-49a5-9c62-d78f27af39b4	2023-12-08	Warnings, Adverse reactions	Name fallback brand name: RANOLAZINE generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Unichem Pharmaceuticals (USA), Inc.	e2a8c9f9-5f6a-4496-8fd6-2439e564db4f	2023-11-06	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Camber Pharmaceuticals, Inc.	82948cdb-73af-4f3f-bd03-628ed0fdbfba	2022-05-13	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
RANOLAZINE	RANOLAZINE	i3 Pharmaceuticals, LLC	de3185bf-448a-15f7-e053-2995a90a9a2e	2022-05-04	Warnings, Adverse reactions	Name fallback brand name: RANOLAZINE generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Proficient Rx LP	989e1688-a0b5-4297-bf91-234de2a0b445	2022-03-01	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Westminster Pharmaceuticals, LLC	b91e88a0-04d0-4d0d-92d8-966b27a48e29	2021-09-02	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Sun Pharmaceutical Industries, Inc.	c5848232-b7fd-4fe5-a543-16d6c4b5c0b1	2020-08-17	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
43975-289	Ranolazine	Ranolazine	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-289	Ranolazine	Ranolazine	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-289	Ranolazine	Ranolazine	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-289	Ranolazine	Ranolazine	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-290	Ranolazine	Ranolazine	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-290	Ranolazine	Ranolazine	ANI Pharmaceuticals, Inc.	ANDA	Current
43975-290	Ranolazine	Ranolazine	Amerigen Pharmaceuticals Inc.	ANDA	Current
43975-290	Ranolazine	Ranolazine	ANI Pharmaceuticals, Inc.	ANDA	Current