Application 211707

Type: ANDA
Sponsor: SUN PHARM

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 42.

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
A211707-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL			2019-05-28
A211707-002	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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL			2019-05-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL			2019-05-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL			2019-05-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL			2019-05-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL			2019-05-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL			2019-05-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL			2019-05-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL			2019-05-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-05-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-05-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-05-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-05-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-05-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-05-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-05-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-05-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-05-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-05-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	RS	2019-05-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211707-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211707-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-05-28	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 74 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211707-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211707-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211707-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211707-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211707-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211707-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211707-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211707-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211707-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211707-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211707-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211707-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211707-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211707-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211707-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211707-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211707-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211707-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211707-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211707-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211707-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211707-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211707-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211707-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211707-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211707-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211707-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211707-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211707-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211707-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211707-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211707-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211707-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211707-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211707-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211707-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211707-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A211707-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211707-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A211707-002	AB	1	`8869cabd3fbd…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Ranolazine	RANOLAZINE	Sun Pharmaceutical Industries, Inc.	c5848232-b7fd-4fe5-a543-16d6c4b5c0b1	2020-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211707 application number: ANDA211707 ndc (product): 63304-017 ndc (product): 63304-018

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
63304-017	Ranolazine	Ranolazine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-017	Ranolazine	Ranolazine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-017	Ranolazine	Ranolazine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-017	Ranolazine	Ranolazine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-018	Ranolazine	Ranolazine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-018	Ranolazine	Ranolazine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-018	Ranolazine	Ranolazine	Sun Pharmaceutical Industries, Inc.	ANDA	Current
63304-018	Ranolazine	Ranolazine	Sun Pharmaceutical Industries, Inc.	ANDA	Current