Application 212781

Type: ANDA
Sponsor: SUNGEN PHARMA

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
A212781-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-03-23
A212781-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2020-03-23

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212781-001	AB
A212781-002	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 · 74 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	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212781-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212781-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-03-23	`87673890dc5c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A212781-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A212781-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212781-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212781-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212781-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A212781-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212781-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212781-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212781-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212781-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212781-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212781-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212781-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212781-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212781-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212781-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212781-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212781-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212781-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A212781-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212781-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212781-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212781-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212781-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212781-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212781-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212781-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A212781-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212781-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212781-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212781-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A212781-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212781-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A212781-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212781-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A212781-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212781-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A212781-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212781-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A212781-002	AB	1	`87673890dc5c…`

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	SunGen Pharma LLC	f3c09979-a44a-4197-97d2-29a207b6fc73	2026-03-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212781 application number: ANDA212781 ndc (product): 70625-206 ndc (product): 70625-207
Ranolazine	RANOLAZINE	AvKARE	b2a8dc3e-a880-5241-e053-2995a90a933a	2026-01-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212781 application number: ANDA212781 ndc (product): 42291-774 ndc (product): 42291-773
Ranolazine	RANOLAZINE	Aphena Pharma Solutions - Tennessee, LLC	abb32182-46ba-49d2-b2ac-13de2ecf802d	2024-04-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212781 application number: ANDA212781 ndc (product): 71610-518

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-773	Ranolazine	RANOLAZINE	AvKARE	ANDA	Current
42291-773	Ranolazine	RANOLAZINE	AvKARE	ANDA	Current
42291-774	Ranolazine	RANOLAZINE	AvKARE	ANDA	Current
42291-774	Ranolazine	RANOLAZINE	AvKARE	ANDA	Current
70625-206	Ranolazine	RANOLAZINE	SunGen Pharma LLC	ANDA	Current
70625-206	Ranolazine	RANOLAZINE	Praxgen Pharmaceuticals LLC	ANDA	Current
70625-207	Ranolazine	RANOLAZINE	SunGen Pharma LLC	ANDA	Current
70625-207	Ranolazine	RANOLAZINE	Praxgen Pharmaceuticals LLC	ANDA	Current
71610-518	Ranolazine	RANOLAZINE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current