Application 020865

Type: NDA
Sponsor: MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MAXALT-MLT	RIZATRIPTAN BENZOATE	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No
002	MAXALT-MLT	RIZATRIPTAN BENZOATE	TABLET, ORALLY DISINTEGRATING;ORAL	EQ 10MG BASE	Yes	Yes

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
N020865-001	MAXALT-MLT	RIZATRIPTAN BENZOATE	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29
N020865-002	MAXALT-MLT	RIZATRIPTAN BENZOATE	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020865-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020865-001	MAXALT-MLT	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020865-001	MAXALT-MLT	EQ 5MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020865-001	MAXALT-MLT	EQ 5MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	1998-06-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020865-002	MAXALT-MLT	EQ 10MG BASE	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	1998-06-29	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N020865-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020865-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020865-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020865-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020865-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020865-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020865-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020865-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020865-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020865-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020865-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020865-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020865-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020865-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020865-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020865-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020865-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020865-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020865-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020865-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020865-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020865-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020865-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020865-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020865-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020865-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020865-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020865-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020865-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020865-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020865-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020865-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020865-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020865-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020865-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020865-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020865-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020865-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020865-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020865-002	AB	1	`cb3db0bc1861…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MAXALT	RIZATRIPTAN BENZOATE	Organon LLC	007b4644-e0e7-4863-9ae3-fe09676b3f5f	2026-01-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020865 application number: NDA020865 ndc (product): 78206-143

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0006-3800	MAXALT-MLT	rizatriptan benzoate	Merck Sharp & Dohme Corp.	NDA	Current
0006-3800	MAXALT-MLT	rizatriptan benzoate	Merck Sharp & Dohme Corp.	NDA	Current
0006-3801	MAXALT-MLT	rizatriptan benzoate	Merck Sharp & Dohme Corp.	NDA	Current
0006-3801	MAXALT-MLT	rizatriptan benzoate	Merck Sharp & Dohme Corp.	NDA	Current
0006-3801	MAXALT-MLT	rizatriptan benzoate	Merck Sharp & Dohme Corp.	NDA	Current
0006-3801	MAXALT-MLT	rizatriptan benzoate	Merck Sharp & Dohme Corp.	NDA	Current
78206-143	MAXALT-MLT	rizatriptan benzoate	Organon LLC	NDA	Current
78206-143	MAXALT-MLT	rizatriptan benzoate	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
60195	SUPPL	2019-10-02
60192	SUPPL	2019-10-02
26081	SUPPL	2011-12-21
3613	SUPPL	2011-12-21
3612	SUPPL	2011-12-21
3611	SUPPL	2011-12-21
3610	SUPPL	2011-12-21
35534	SUPPL	2011-12-20
35533	SUPPL	2011-12-20
35532	SUPPL	2011-12-20
35531	SUPPL	2011-12-20
13643	SUPPL	2011-12-20
13642	SUPPL	2010-08-19
26082	SUPPL	2010-08-16
41771	SUPPL	2008-08-01
41769	SUPPL	2004-06-09
41770	SUPPL	2004-04-21
41768	SUPPL	2004-04-21
21031	SUPPL	2004-04-21
21030	SUPPL	2004-04-21
44078	ORIG	2003-12-12
3609	SUPPL	2002-04-22
3608	SUPPL	1999-11-23
41767	ORIG	1999-04-08
13641	ORIG	1998-06-29
3607	ORIG	1998-06-29
53406	ORIG	1900-01-01
53405	ORIG	1900-01-01
53404	ORIG	1900-01-01
53403	ORIG	1900-01-01
53402	ORIG	1900-01-01
53401	ORIG	1900-01-01
53400	ORIG	1900-01-01
53399	ORIG	1900-01-01