Application 211829

Type: ANDA
Sponsor: SCIEGEN 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 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
A211829-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2019-06-04
A211829-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2019-06-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211829-001	AB
A211829-002	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 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	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211829-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211829-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2019-06-04	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A211829-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211829-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211829-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211829-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211829-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211829-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211829-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211829-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211829-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211829-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211829-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211829-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211829-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211829-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211829-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211829-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211829-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211829-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211829-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211829-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211829-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211829-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211829-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211829-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211829-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211829-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211829-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211829-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211829-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211829-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211829-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211829-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211829-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211829-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211829-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A211829-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211829-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211829-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211829-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A211829-002	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 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RANOLAZINE	RANOLAZINE	Radha Pharmaceuticals, Inc	38d2833d-44b8-8d46-e063-6394a90a74d8	2026-02-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211829 application number: ANDA211829
RANOLAZINE	RANOLAZINE	Aphena Pharma Solutions - Tennessee, LLC	45236b7d-3728-1e13-e063-6394a90ad77f	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211829 application number: ANDA211829
RANOLAZINE	RANOLAZINE	ScieGen Pharmaceuticals, Inc	71d50258-75b7-4801-b0f4-c34fe883d57d	2024-12-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211829 application number: ANDA211829 ndc (product): 50228-424 ndc (product): 50228-423
Ranolazine	RANOLAZINE	Proficient Rx LP	c7ed8234-e6bd-4f19-a1ce-40f272a79036	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211829 application number: ANDA211829
Ranolazine	RANOLAZINE	Proficient Rx LP	989e1688-a0b5-4297-bf91-234de2a0b445	2022-03-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211829 application number: ANDA211829 ndc (product): 71205-868 ndc (product): 71205-867
Ranolazine	RANOLAZINE	Westminster Pharmaceuticals, LLC	b91e88a0-04d0-4d0d-92d8-966b27a48e29	2021-09-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211829 application number: ANDA211829 ndc (product): 69367-293 ndc (product): 69367-294

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50228-423	RANOLAZINE	RANOLAZINE	ScieGen Pharmaceuticals, Inc	ANDA	Current
50228-423	RANOLAZINE	RANOLAZINE	ScieGen Pharmaceuticals, Inc	ANDA	Current
50228-424	RANOLAZINE	RANOLAZINE	ScieGen Pharmaceuticals, Inc	ANDA	Current
50228-424	RANOLAZINE	RANOLAZINE	ScieGen Pharmaceuticals, Inc	ANDA	Current
51407-225	RANOLAZINE	RANOLAZINE	Golden State Medical Supply Inc.	ANDA	Current
51407-225	RANOLAZINE	RANOLAZINE	Golden State Medical Supply	ANDA	Current
51407-225	RANOLAZINE	RANOLAZINE	Golden State Medical Supply	ANDA	Current
51407-226	RANOLAZINE	RANOLAZINE	Golden State Medical Supply Inc.	ANDA	Current
51407-226	RANOLAZINE	RANOLAZINE	Golden State Medical Supply	ANDA	Current
69367-293	Ranolazine	Ranolazine	Westminster Pharmaceuticals, LLC	ANDA	Current
69367-294	Ranolazine	Ranolazine	Westminster Pharmaceuticals, LLC	ANDA	Current
71205-867	Ranolazine	Ranolazine	Proficient Rx LP	ANDA	Current
71205-867	Ranolazine	Ranolazine	Proficient Rx LP	ANDA	Current
71205-868	Ranolazine	Ranolazine	Proficient Rx LP	ANDA	Current
71205-868	Ranolazine	Ranolazine	Proficient Rx LP	ANDA	Current
71610-322	RANOLAZINE	RANOLAZINE	Aphena Pharma Solutions - Tennessee, LLC	ANDA	Current