Application 203476

Type: ANDA
Sponsor: SUN PHARMA GLOBAL

Application Products#

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

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
A203476-001	ZOLMITRIPTAN	ZOLMITRIPTAN	2.5MG	TABLET / ORAL			2014-11-13
A203476-002	ZOLMITRIPTAN	ZOLMITRIPTAN	5MG	TABLET / ORAL			2014-11-13

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A203476-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	2014-11-13	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A203476-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	2014-11-13	`74a2ff9319b5…`

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 brand name: Zolmitriptan 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 brand name: Zolmitriptan generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Alembic Pharmaceuticals Limited	75a92ce1-eade-4b71-80ab-d7fd1f57e352	2023-01-30	Warnings, Adverse reactions	Name fallback brand name: Zolmitriptan generic name: ZOLMITRIPTAN
zolmitriptan	ZOLMITRIPTAN	Padagis Israel Pharmaceuticals Ltd	24e12658-eb42-4d1f-9192-9c4298416d51	2022-11-01	Warnings, Adverse reactions	Name fallback brand name: zolmitriptan generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Cipla USA Inc.	16e520fe-2f57-400b-8ee5-9a3f89037d6c	2019-10-29	Warnings, Adverse reactions	Name fallback brand name: Zolmitriptan generic name: ZOLMITRIPTAN
Zolmitriptan	ZOLMITRIPTAN	Amneal Pharmaceuticals NY LLC	05a40502-149d-41bd-966e-771e937a955b	2019-04-30	Warnings, Adverse reactions	Name fallback brand name: Zolmitriptan generic name: ZOLMITRIPTAN

Reported adverse events (FAERS/openFDA)#

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