Application 208862

Type: ANDA
Sponsor: ACTAVIS ELIZABETH

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
A208862-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL			2019-05-28
A208862-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL			2019-05-28

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
2026-02-19 14:30 UTC	2026-02	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208862-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208862-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-05-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A208862-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208862-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208862-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208862-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208862-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208862-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208862-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208862-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208862-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208862-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208862-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208862-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208862-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208862-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208862-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208862-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208862-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208862-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208862-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208862-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208862-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208862-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208862-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208862-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208862-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208862-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208862-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A208862-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208862-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208862-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208862-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A208862-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208862-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A208862-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208862-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A208862-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208862-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A208862-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208862-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A208862-002	AB	1	`782e0a99824c…`

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 2 · 32 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ranolazine	RANOLAZINE	Major Pharmaceuticals	6166c40c-4fbe-47c4-92e4-2dc5d3567a86	2026-06-09	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Lifestar Pharma LLC	195c4b51-fec2-410d-8d90-487c536a8728	2026-05-06	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Zameer Pharmaceuticals LLC	5f4fc8a4-2bd5-4378-8882-e739c951390e	2026-04-21	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Torrent Pharma, Inc.	d2454377-2abd-4d9f-85f1-12f1adbb10e5	2026-04-15	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	SunGen Pharma LLC	f3c09979-a44a-4197-97d2-29a207b6fc73	2026-03-25	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
RANOLAZINE	RANOLAZINE	Radha Pharmaceuticals, Inc	38d2833d-44b8-8d46-e063-6394a90a74d8	2026-02-20	Warnings, Adverse reactions	Name fallback brand name: RANOLAZINE generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Zydus Lifesciences Limited	d74f3dea-7357-4e9a-be9a-2f498a44108a	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Viona Pharmaceuticals Inc	00979fb3-d70f-493d-94ca-2914cbadaa9d	2026-01-29	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Glenmark Pharmaceuticals Inc., USA	0cf58732-c242-49b0-8e3f-248778b4458d	2026-01-23	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	NCS HealthCare of KY, LLC dba Vangard Labs	2373687b-b9a4-496e-b89f-9754f8513fd3	2026-01-21	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	AvKARE	b2a8dc3e-a880-5241-e053-2995a90a933a	2026-01-15	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	AvPAK	e92350e8-5b0b-95d3-e053-2995a90a959b	2026-01-09	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
RANOLAZINE	RANOLAZINE	Aphena Pharma Solutions - Tennessee, LLC	45236b7d-3728-1e13-e063-6394a90ad77f	2025-12-04	Warnings, Adverse reactions	Name fallback brand name: RANOLAZINE generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Ajanta Pharma USA Inc.	8bfd1a61-547a-4847-ae4e-480b17da6272	2025-10-28	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Ascend Laboratories, LLC	5b254a8e-db88-49be-bb48-e6d2847f8ab3	2025-07-28	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
RANOLAZINE	RANOLAZINE	A2A Integrated Pharmaceuticals	9fb62878-c76a-4be2-99be-962ce2956af2	2025-02-28	Warnings, Adverse reactions	Name fallback brand name: RANOLAZINE generic name: RANOLAZINE
ASPRUZYO SPRINKLE	RANOLAZINE	SUN PHARMACEUTICAL INDUSTRIES, INC.	dd9f81e4-50da-4551-aed5-559d304df42e	2025-01-29	Warnings, Adverse reactions	Name fallback generic name: RANOLAZINE
RANOLAZINE	RANOLAZINE	Bryant Ranch Prepack	9199e28a-ddbe-46a4-ab26-9b08034289be	2025-01-23	Warnings, Adverse reactions	Name fallback brand name: RANOLAZINE generic name: RANOLAZINE
Ranolazine	RANOLAZINE	Bryant Ranch Prepack	2e678c80-1410-433b-8c48-4b210eceb0de	2025-01-17	Warnings, Adverse reactions	Name fallback brand name: Ranolazine generic name: RANOLAZINE
RANOLAZINE	RANOLAZINE	ScieGen Pharmaceuticals, Inc	71d50258-75b7-4801-b0f4-c34fe883d57d	2024-12-24	Warnings, Adverse reactions	Name fallback brand name: RANOLAZINE generic name: RANOLAZINE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
45963-418	Ranolazine	Ranolazine	Actavis Pharma, Inc.	ANDA	Current
45963-418	Ranolazine	Ranolazine	Actavis Pharma, Inc.	ANDA	Current
45963-418	Ranolazine	Ranolazine	Actavis Pharma, Inc.	ANDA	Current
45963-418	Ranolazine	Ranolazine	Actavis Pharma, Inc.	ANDA	Current
45963-418	Ranolazine	Ranolazine	Actavis Pharma, Inc.	ANDA	Current
45963-419	Ranolazine	Ranolazine	Actavis Pharma, Inc.	ANDA	Current
45963-419	Ranolazine	Ranolazine	Actavis Pharma, Inc.	ANDA	Current
45963-419	Ranolazine	Ranolazine	Actavis Pharma, Inc.	ANDA	Current
45963-419	Ranolazine	Ranolazine	Actavis Pharma, Inc.	ANDA	Current
45963-419	Ranolazine	Ranolazine	Actavis Pharma, Inc.	ANDA	Current