Application 207867

Type: ANDA
Sponsor: PLD ACQUISITIONS LLC

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
A207867-001	ZOLMITRIPTAN	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB		2017-02-27
A207867-002	ZOLMITRIPTAN	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB		2017-02-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207867-001	AB
A207867-002	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	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207867-001	ZOLMITRIPTAN	2.5MG	TABLET / ORAL	AB	2017-02-27	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207867-002	ZOLMITRIPTAN	5MG	TABLET / ORAL	AB	2017-02-27	`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	A207867-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207867-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207867-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207867-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207867-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207867-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207867-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207867-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207867-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207867-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207867-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207867-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207867-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207867-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207867-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207867-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207867-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207867-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207867-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207867-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207867-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207867-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207867-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207867-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207867-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207867-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207867-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207867-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207867-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207867-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207867-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207867-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207867-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207867-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207867-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207867-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207867-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207867-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207867-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207867-002	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ZOMIG	ZOLMITRIPTAN	Amneal Pharmaceuticals LLC	1d977430-f494-415d-9daf-3c3163156249	2024-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207867 application number: ANDA207867
Zolmitriptan	ZOLMITRIPTAN	Medstone Pharma LLC	c970dd17-abdb-4fac-8de8-984e388b498c	2023-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207867 application number: ANDA207867 ndc (product): 71626-101 ndc (product): 71626-102
Zolmitriptan	ZOLMITRIPTAN	PLD Acquisitions LLC DBA Avma Pharma Solutions	f59bfbdd-7f4b-4a29-8396-e144dde65878	2023-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207867 application number: ANDA207867 ndc (product): 63548-0102 ndc (product): 63548-0101

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
63548-0101	Zolmitriptan	Zolmitriptan	PLD Acquisitions LLC DBA Av	ANDA	Current
63548-0101	Zolmitriptan	Zolmitriptan	PLD Acquisitions LLC DBA Av	ANDA	Current
63548-0102	Zolmitriptan	Zolmitriptan	PLD Acquisitions LLC DBA Av	ANDA	Current
63548-0102	Zolmitriptan	Zolmitriptan	PLD Acquisitions LLC DBA Av	ANDA	Current
71626-101	Zolmitriptan	Zolmitriptan	Medstone Pharma LLC	ANDA	Current
71626-101	Zolmitriptan	Zolmitriptan	Medstone Pharma LLC	ANDA	Current
71626-101	Zolmitriptan	Zolmitriptan	Medstone Pharma LLC	ANDA	Current
71626-102	Zolmitriptan	Zolmitriptan	Medstone Pharma LLC	ANDA	Current
71626-102	Zolmitriptan	Zolmitriptan	Medstone Pharma LLC	ANDA	Current
71626-102	Zolmitriptan	Zolmitriptan	Medstone Pharma LLC	ANDA	Current
73358-101	Zolmitriptan	zolmitriptan	Curae Pharma360 Inc	ANDA	Current
73358-101	Zolmitriptan	zolmitriptan	Curae Pharma360 LLC	ANDA	Current