Application 203269

Type: ANDA
Sponsor: ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	TABLET;ORAL	EQ 5MG BASE	No	No
002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	TABLET;ORAL	EQ 10MG BASE	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
A203269-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB		2016-02-18
A203269-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB		2016-02-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203269-001	AB
A203269-002	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	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203269-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET / ORAL	AB	2016-02-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203269-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET / ORAL	AB	2016-02-18	`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	A203269-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203269-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203269-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203269-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203269-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203269-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203269-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203269-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203269-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203269-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203269-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203269-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203269-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203269-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203269-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203269-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203269-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203269-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203269-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203269-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203269-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203269-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203269-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203269-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203269-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203269-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203269-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203269-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203269-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203269-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203269-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203269-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203269-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203269-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203269-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203269-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203269-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203269-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203269-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203269-002	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	6391d2a1-252e-4e50-9d80-4dce12eabc8f	2025-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203269 application number: ANDA203269
RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	Direct Rx	d60560d5-8e52-099d-e053-2a95a90a20af	2025-01-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203269 application number: ANDA203269 ndc (product): 72189-316
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Bryant Ranch Prepack	65ae33a2-975f-4a4e-a1a5-42fe451a2434	2023-03-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203269 application number: ANDA203269 ndc (product): 71335-2031
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	A-S Medication Solutions	5001b8cc-8e52-4a00-a830-3b2f79766a03	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203269 application number: ANDA203269 ndc (product): 50090-3343
Rizatriptan Benzoate	RIZATRIPTAN BENZOATE	Ascend Laboratories, LLC	07e66554-bc85-4853-9f40-1249617630a9	2022-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203269 application number: ANDA203269 ndc (product): 67877-262 ndc (product): 67877-261

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3343	Rizatriptan Benzoate	Rizatriptan Benzoate	A-S Medication Solutions	ANDA	Current
50090-3343	Rizatriptan Benzoate	Rizatriptan Benzoate	A-S Medication Solutions	ANDA	Current
53002-3713	Rizatriptan Benzoate	Rizatriptan Benzoate	RPK Pharmaceuticals, Inc.	ANDA	Current
63629-8122	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
63629-8122	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
67877-261	Rizatriptan Benzoate	Rizatriptan Benzoate	Ascend Laboratories, LLC	ANDA	Current
67877-261	Rizatriptan Benzoate	Rizatriptan Benzoate	Ascend Laboratories, LLC	ANDA	Current
67877-261	Rizatriptan Benzoate	Rizatriptan Benzoate	Ascend Laboratories, LLC	ANDA	Current
67877-261	Rizatriptan Benzoate	Rizatriptan Benzoate	Ascend Laboratories, LLC	ANDA	Current
67877-262	Rizatriptan Benzoate	Rizatriptan Benzoate	Ascend Laboratories, LLC	ANDA	Current
67877-262	Rizatriptan Benzoate	Rizatriptan Benzoate	Ascend Laboratories, LLC	ANDA	Current
67877-262	Rizatriptan Benzoate	Rizatriptan Benzoate	Ascend Laboratories, LLC	ANDA	Current
67877-262	Rizatriptan Benzoate	Rizatriptan Benzoate	Ascend Laboratories, LLC	ANDA	Current
71335-1283	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
71335-1283	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
71335-1283	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
71335-1577	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
71335-1577	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
71335-2031	Rizatriptan Benzoate	Rizatriptan Benzoate	Bryant Ranch Prepack	ANDA	Current
72189-316	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	Direct Rx	ANDA	Current