Application 020768

Type: NDA
Sponsor: IPR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOMIG	ZOLMITRIPTAN	TABLET;ORAL	2.5MG	Yes	No
002	ZOMIG	ZOLMITRIPTAN	TABLET;ORAL	5MG	Yes	Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N020768-001	ZOMIG	ZOLMITRIPTAN	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-11-25
N020768-002	ZOMIG	ZOLMITRIPTAN	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-11-25

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 · 86 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
2026-09-14 22:38:34	2026-08	N020768-001	ZOMIG	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-11-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N020768-002	ZOMIG	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-11-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020768-001	ZOMIG	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-11-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020768-002	ZOMIG	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-11-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020768-001	ZOMIG	2.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-11-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020768-002	ZOMIG	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1997-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020768-001	ZOMIG	2.5MG	TABLET / ORAL		RLD	1997-11-25	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020768-002	ZOMIG	5MG	TABLET / ORAL		RLD	1997-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020768-001	ZOMIG	2.5MG	TABLET / ORAL	AB	RLD	1997-11-25	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020768-002	ZOMIG	5MG	TABLET / ORAL	AB	RLD, RS	1997-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020768-001	ZOMIG	2.5MG	TABLET / ORAL	AB	RLD	1997-11-25	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020768-002	ZOMIG	5MG	TABLET / ORAL	AB	RLD, RS	1997-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020768-001	ZOMIG	2.5MG	TABLET / ORAL	AB	RLD	1997-11-25	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020768-002	ZOMIG	5MG	TABLET / ORAL	AB	RLD, RS	1997-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020768-001	ZOMIG	2.5MG	TABLET / ORAL	AB	RLD	1997-11-25	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020768-002	ZOMIG	5MG	TABLET / ORAL	AB	RLD, RS	1997-11-25	`74a2ff9319b5…`

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	N020768-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020768-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020768-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020768-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020768-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020768-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020768-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020768-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020768-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020768-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020768-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020768-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020768-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020768-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020768-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020768-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020768-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020768-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020768-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N020768-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020768-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N020768-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020768-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N020768-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020768-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N020768-002	AB	1	`ea99ee380514…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020768-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020768-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020768-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	N020768-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020768-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	N020768-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020768-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020768-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020768-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	N020768-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020768-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	N020768-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020768-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020768-002	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 2 of 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Zolmitriptan	ZOLMITRIPTAN	Medstone Pharma LLC	c970dd17-abdb-4fac-8de8-984e388b498c	2023-04-25	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	PLD Acquisitions LLC DBA Avma Pharma Solutions	f59bfbdd-7f4b-4a29-8396-e144dde65878	2023-02-09	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Alembic Pharmaceuticals Limited	75a92ce1-eade-4b71-80ab-d7fd1f57e352	2023-01-30	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
zolmitriptan	ZOLMITRIPTAN	Padagis Israel Pharmaceuticals Ltd	24e12658-eb42-4d1f-9192-9c4298416d51	2022-11-01	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Cipla USA Inc.	16e520fe-2f57-400b-8ee5-9a3f89037d6c	2019-10-29	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Amneal Pharmaceuticals NY LLC	05a40502-149d-41bd-966e-771e937a955b	2019-04-30	Warnings, Adverse reactions	Name fallback generic name: ZOLMITRIPTAN

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0115-0671	Zolmitriptan	Zolmitriptan	Impax Generics	NDA	Current
0115-0672	Zolmitriptan	Zolmitriptan	Impax Generics	NDA	Current
64896-671	ZOMIG	Zolmitriptan	Impax Specialty Pharma	NDA	Current
64896-671	ZOMIG	Zolmitriptan	Amneal Pharmaceuticals	NDA	Current
64896-671	ZOMIG	Zolmitriptan	Amneal Pharmaceuticals	NDA	Current
64896-671	ZOMIG	Zolmitriptan	Amneal Pharmaceuticals	NDA	Current
64896-672	ZOMIG	Zolmitriptan	Impax Specialty Pharma	NDA	Current
64896-672	ZOMIG	Zolmitriptan	Amneal Pharmaceuticals	NDA	Current
64896-672	ZOMIG	Zolmitriptan	Amneal Pharmaceuticals	NDA	Current
64896-672	ZOMIG	Zolmitriptan	Amneal Pharmaceuticals	NDA	Current
68258-7103	ZOMIG	Zolmitriptan	Dispensing Solutions, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
57075	SUPPL	2018-12-31
57030	SUPPL	2018-12-26
35311	SUPPL	2012-09-18
25756	SUPPL	2012-09-18
13387	SUPPL	2012-09-18
3305	SUPPL	2012-09-18
35310	SUPPL	2010-08-19
3304	SUPPL	2010-08-16
20926	ORIG	2010-01-29
20927	SUPPL	2008-02-19
23598	ORIG	2007-01-17
13386	SUPPL	2004-11-19
3302	SUPPL	2004-11-19
3303	SUPPL	2004-01-14
3301	SUPPL	2003-06-08
25755	SUPPL	2002-10-09
25754	SUPPL	2002-01-29
63742	SUPPL	1900-01-01
52231	SUPPL	1900-01-01
52230	SUPPL	1900-01-01
52229	SUPPL	1900-01-01
52228	SUPPL	1900-01-01
52227	SUPPL	1900-01-01