Application 021231

Type: NDA
Sponsor: ASTRAZENECA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOMIG-ZMT	ZOLMITRIPTAN	TABLET, ORALLY DISINTEGRATING;ORAL	2.5MG	Yes	No
002	ZOMIG-ZMT	ZOLMITRIPTAN	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	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
N021231-001	ZOMIG-ZMT	ZOLMITRIPTAN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13
N021231-002	ZOMIG-ZMT	ZOLMITRIPTAN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17

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UTC	2026-02	N021231-001	ZOMIG-ZMT	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021231-002	ZOMIG-ZMT	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-02-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL		RLD	2001-09-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-02-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-09-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-02-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-09-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-02-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-09-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-02-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-09-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-02-13	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-09-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021231-001	ZOMIG-ZMT	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD	2001-02-13	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021231-002	ZOMIG-ZMT	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RLD, RS	2001-09-17	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021231-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021231-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021231-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021231-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021231-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021231-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021231-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021231-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021231-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021231-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021231-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021231-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021231-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021231-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021231-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021231-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021231-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021231-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021231-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021231-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021231-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021231-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021231-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021231-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021231-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021231-002	AB	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021231-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021231-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021231-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N021231-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021231-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N021231-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021231-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021231-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021231-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N021231-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021231-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N021231-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021231-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021231-002	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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zolmitriptan	ZOLMITRIPTAN	BluePoint Laboratories	e6628b7a-0b63-4e6f-a5e7-2fa195265235	2026-04-16	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Glenmark Pharmaceuticals Inc.,USA	333caafc-2e63-49f8-a0c6-534e528d228d	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
zolmiptriptan	ZOLMITRIPTAN	Glenmark Pharmaceuticals Inc., USA	a734b368-6008-441c-ab44-5634e46be9a4	2026-01-29	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Ajanta Pharma USA Inc.	b5c5cb44-7581-4856-8324-13c02a6101dd	2025-11-05	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
zolmitriptan	ZOLMITRIPTAN	Bryant Ranch Prepack	7a6924da-37a0-4e43-b57d-410b5179361b	2025-10-24	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan OD	ZOLMITRIPTAN	Jubilant Cadista Pharmacuticals Inc.	a6a32fc6-4243-9cdd-91c7-b8a58e0f9811	2025-10-07	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan OD	ZOLMITRIPTAN	AvKARE	3f0040a6-b1d6-3d73-e063-6294a90af23c	2025-09-17	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Asclemed USA, Inc.	0b37962f-253b-4dc9-9ed2-ff44d2370e51	2025-05-02	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
zolmitriptan	ZOLMITRIPTAN	Bryant Ranch Prepack	e304c986-24fa-451e-a560-0af658ba387b	2025-04-02	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Direct_Rx	f6ca7d28-8322-f151-e053-6394a90a39b7	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Direct_Rx	f6ca22bf-caf1-89af-e053-6394a90a2987	2025-01-22	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Zydus Lifesciences Limited	aae2d9cb-9938-4032-961f-f0afd1958b5d	2024-08-14		Name fallback generic name: ZOLMITRIPTAN
zolmitriptan	ZOLMITRIPTAN	Bryant Ranch Prepack	8b4e77de-3185-4d1e-946a-96b785b76da0	2024-08-14	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Alembic Pharmaceuticals Limited	b8d657ac-dbda-4455-8bb5-3896951c3b67	2024-02-22	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Alembic Pharmaceuticals Inc.	89bfee8d-1ddf-4fb2-a565-ce32f096a25d	2024-02-20	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Aurobindo Pharma Limited	9212b076-b1ae-4c06-bd56-0ae3c5c9acdf	2024-02-17	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Rising Pharma Holdings, Inc.	5fcdc5d6-38fa-458d-a581-4e3678a9e8fd	2024-02-17	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
ZOMIG	ZOLMITRIPTAN	Amneal Pharmaceuticals LLC	1d977430-f494-415d-9daf-3c3163156249	2024-02-14	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Alembic Pharmaceuticals Inc.	cd6203d4-02b5-43b2-9460-16a4d932ed51	2024-01-12	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Zydus Pharmaceuticals USA Inc.	7fc95729-2f5d-4d5c-b26c-3a13854f73e3	2023-11-08	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 10 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-0691	Zolmitriptan Orally Disintegrating	Zolmitriptan	Impax Generics	NDA	Current
0115-0692	Zolmitriptan Orally Disintegrating	Zolmitriptan	Impax Generics	NDA	Current
64896-691	ZOMIG ZMT	Zolmitriptan	Impax Specialty Pharma	NDA	Current
64896-691	ZOMIG ZMT	Zolmitriptan	Amneal Pharmaceuticals	NDA	Current
64896-691	ZOMIG ZMT	Zolmitriptan	Amneal Pharmaceuticals	NDA	Current
64896-691	ZOMIG ZMT	Zolmitriptan	Amneal Pharmaceuticals	NDA	Current
64896-692	ZOMIG ZMT	Zolmitriptan	Impax Specialty Pharma	NDA	Current
64896-692	ZOMIG ZMT	Zolmitriptan	Amneal Pharmaceuticals	NDA	Current
64896-692	ZOMIG ZMT	Zolmitriptan	Amneal Pharmaceuticals	NDA	Current
64896-692	ZOMIG ZMT	Zolmitriptan	Amneal Pharmaceuticals	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57076	SUPPL	2018-12-31
57031	SUPPL	2018-12-26
36422	SUPPL	2012-09-18
27153	SUPPL	2012-09-18
14690	SUPPL	2012-09-18
4718	SUPPL	2012-09-18
14689	SUPPL	2010-08-19
4717	SUPPL	2010-08-16
21529	SUPPL	2008-02-19
23637	ORIG	2007-01-17
21528	ORIG	2004-06-14
27152	SUPPL	2004-01-14
4716	SUPPL	2003-06-08
4715	SUPPL	2002-10-09
14688	ORIG	2001-02-13
4714	ORIG	2001-02-13