Application 207021

Type: ANDA
Sponsor: AUROBINDO PHARMA LTD

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 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
A207021-001	ZOLMITRIPTAN	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB		2016-05-11
A207021-002	ZOLMITRIPTAN	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB		2016-05-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207021-001	AB
A207021-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207021-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2016-05-11	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207021-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2016-05-11	`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	A207021-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207021-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207021-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207021-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207021-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207021-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207021-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207021-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207021-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207021-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207021-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207021-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207021-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207021-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207021-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207021-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207021-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207021-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207021-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207021-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207021-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207021-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207021-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207021-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207021-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207021-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207021-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207021-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207021-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207021-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207021-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207021-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207021-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207021-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207021-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207021-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207021-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207021-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207021-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207021-002	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	Aurobindo Pharma Limited	9212b076-b1ae-4c06-bd56-0ae3c5c9acdf	2024-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207021 application number: ANDA207021 ndc (product): 65862-914 ndc (product): 65862-915
Zolmitriptan	ZOLMITRIPTAN	Rising Pharma Holdings, Inc.	5fcdc5d6-38fa-458d-a581-4e3678a9e8fd	2024-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207021 application number: ANDA207021 ndc (product): 16571-803 ndc (product): 16571-804

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
16571-803	Zolmitriptan	Zolmitriptan	Rising Pharma Holdings, Inc.	ANDA	Current
16571-803	Zolmitriptan	Zolmitriptan	Rising Pharma Holdings, Inc.	ANDA	Current
16571-804	Zolmitriptan	Zolmitriptan	Rising Pharma Holdings, Inc.	ANDA	Current
16571-804	Zolmitriptan	Zolmitriptan	Rising Pharma Holdings, Inc.	ANDA	Current
65862-914	Zolmitriptan	Zolmitriptan	Aurobindo Pharma Limited	ANDA	Current
65862-914	Zolmitriptan	Zolmitriptan	Aurobindo Pharma Limited	ANDA	Current
65862-914	Zolmitriptan	Zolmitriptan	Aurobindo Pharma Limited	ANDA	Current
65862-915	Zolmitriptan	Zolmitriptan	Aurobindo Pharma Limited	ANDA	Current
65862-915	Zolmitriptan	Zolmitriptan	Aurobindo Pharma Limited	ANDA	Current
65862-915	Zolmitriptan	Zolmitriptan	Aurobindo Pharma Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
10606	ORIG	2016-05-16