Application 203146

Type: ANDA
Sponsor: MACLEODS PHARMS LTD

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 5MG BASE	No	No
002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	TABLET, ORALLY DISINTEGRATING;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
A203146-001	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2014-09-19
A203146-002	RIZATRIPTAN BENZOATE	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2014-09-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203146-001	AB
A203146-002	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	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203146-001	RIZATRIPTAN BENZOATE	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203146-002	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2014-09-19	`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	A203146-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203146-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203146-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203146-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203146-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203146-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203146-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203146-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203146-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203146-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203146-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203146-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203146-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203146-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203146-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203146-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203146-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203146-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203146-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203146-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203146-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203146-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203146-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203146-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203146-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203146-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203146-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203146-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203146-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203146-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203146-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203146-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203146-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203146-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203146-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203146-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A203146-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A203146-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A203146-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A203146-002	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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rizatriptan Benzoate ODT	RIZATRIPTAN BENZOATE ODT	Direct_rx	2c29e066-c018-22e7-e063-6294a90a035c	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203146 application number: ANDA203146
rizatriptan benzoate	RIZATRIPTAN BENZOATE	Macleods Pharmaceuticals Limited	57ed2505-28f1-4292-b3c3-a49bf0f7c683	2023-02-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203146 application number: ANDA203146 ndc (product): 33342-094 ndc (product): 33342-093

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
33342-093	rizatriptan benzoate	rizatriptan benzoate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-093	rizatriptan benzoate	rizatriptan benzoate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-093	rizatriptan benzoate	rizatriptan benzoate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-094	rizatriptan benzoate	rizatriptan benzoate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-094	rizatriptan benzoate	rizatriptan benzoate	Macleods Pharmaceuticals Limited	ANDA	Current
33342-094	rizatriptan benzoate	rizatriptan benzoate	Macleods Pharmaceuticals Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
32383	ORIG	2014-09-23