Application 202890

Type: ANDA
Sponsor: ZYDUS PHARMS USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ZOLMITRIPTAN	ZOLMITRIPTAN	TABLET, ORALLY DISINTEGRATING;ORAL	2.5MG	No	No
002	ZOLMITRIPTAN	ZOLMITRIPTAN	TABLET, ORALLY DISINTEGRATING;ORAL	5MG	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
A202890-001	ZOLMITRIPTAN	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15
A202890-002	ZOLMITRIPTAN	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202890-001	AB
A202890-002	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	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	RS	2013-05-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202890-001	ZOLMITRIPTAN	2.5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202890-002	ZOLMITRIPTAN	5MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2013-05-15	`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	A202890-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202890-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202890-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202890-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202890-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202890-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202890-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202890-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202890-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202890-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202890-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202890-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202890-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202890-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202890-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202890-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202890-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202890-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202890-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202890-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202890-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202890-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202890-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202890-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202890-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202890-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202890-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202890-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202890-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202890-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202890-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202890-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202890-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202890-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202890-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202890-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202890-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202890-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202890-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202890-002	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
Zolmitriptan	ZOLMITRIPTAN	Zydus Lifesciences Limited	aae2d9cb-9938-4032-961f-f0afd1958b5d	2024-08-14		Exact identifier application applno (ANDA): 202890 application number: ANDA202890 ndc (product): 65841-768 ndc (product): 65841-767
Zolmitriptan	ZOLMITRIPTAN	Zydus Pharmaceuticals USA Inc.	7fc95729-2f5d-4d5c-b26c-3a13854f73e3	2023-11-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202890 application number: ANDA202890 ndc (product): 68382-717 ndc (product): 68382-715

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
65841-767	Zolmitriptan	Zolmitriptan	Cadila Healthcare Limited	ANDA	Current
65841-767	Zolmitriptan	Zolmitriptan	Zydus Lifesciences Limited	ANDA	Current
65841-767	Zolmitriptan	Zolmitriptan	Cadila Healthcare Limited	ANDA	Current
65841-768	Zolmitriptan	Zolmitriptan	Cadila Healthcare Limited	ANDA	Current
65841-768	Zolmitriptan	Zolmitriptan	Zydus Lifesciences Limited	ANDA	Current
65841-768	Zolmitriptan	Zolmitriptan	Cadila Healthcare Limited	ANDA	Current
68382-715	Zolmitriptan	Zolmitriptan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-715	Zolmitriptan	Zolmitriptan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-715	Zolmitriptan	Zolmitriptan	Zydus Pharmaceuticals USA Inc.	ANDA	Current
68382-717	Zolmitriptan	Zolmitriptan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-717	Zolmitriptan	Zolmitriptan	Zydus Pharmaceuticals (USA) Inc.	ANDA	Current
68382-717	Zolmitriptan	Zolmitriptan	Zydus Pharmaceuticals USA Inc.	ANDA	Current