Application 209953

Type: ANDA
Sponsor: ALKEM LABS LTD

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
A209953-001	RANOLAZINE	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB		2020-11-30
A209953-002	RANOLAZINE	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB		2020-11-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209953-001	AB
A209953-002	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
2026-08-18 06:07:40	2026-07	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209953-001	RANOLAZINE	500MG	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209953-002	RANOLAZINE	1GM	TABLET, EXTENDED RELEASE / ORAL	AB	2020-11-30	`782e0a99824c…`

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
2026-08-18 06:07:40	2026-07	A209953-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A209953-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209953-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A209953-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209953-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209953-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209953-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A209953-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209953-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209953-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209953-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209953-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209953-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209953-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209953-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209953-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209953-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209953-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209953-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209953-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209953-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A209953-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209953-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209953-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209953-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209953-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209953-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209953-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209953-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A209953-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209953-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209953-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209953-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A209953-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209953-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A209953-002	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A209953-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A209953-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209953-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A209953-002	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 · 3 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	Exact identifier application applno (ANDA): 209953 application number: ANDA209953
Ranolazine	RANOLAZINE	AvPAK	e92350e8-5b0b-95d3-e053-2995a90a959b	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209953 application number: ANDA209953 ndc (product): 50268-723 ndc (product): 50268-722
Ranolazine	RANOLAZINE	Ascend Laboratories, LLC	5b254a8e-db88-49be-bb48-e6d2847f8ab3	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209953 application number: ANDA209953 ndc (product): 67877-525 ndc (product): 67877-526

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50268-722	Ranolazine	Ranolazine	AvPAK	ANDA	Current
50268-723	Ranolazine	Ranolazine	AvPAK	ANDA	Current
67877-525	Ranolazine	Ranolazine	Ascend Laboratories, LLC	ANDA	Current
67877-525	Ranolazine	Ranolazine	Ascend Laboratories, LLC	ANDA	Current
67877-526	Ranolazine	Ranolazine	Ascend Laboratories, LLC	ANDA	Current
67877-526	Ranolazine	Ranolazine	Ascend Laboratories, LLC	ANDA	Current