Application 091326

Type: ANDA
Sponsor: PADDOCK LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE	TABLET;ORAL	EQ 1MG BASE	No	No
002	NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE	TABLET;ORAL	EQ 2.5MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A091326-001	NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL			2010-07-08
A091326-002	NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL			2010-07-08

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 · 84 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
2026-08-18 06:07:40	2026-07	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL		2010-07-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL		2010-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091326-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	AB	2010-07-08	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091326-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	AB	2010-07-08	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 80 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	A091326-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091326-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091326-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091326-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091326-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091326-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091326-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091326-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091326-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091326-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091326-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091326-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091326-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091326-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091326-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091326-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091326-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091326-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091326-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091326-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091326-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091326-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091326-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091326-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091326-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091326-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091326-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091326-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091326-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091326-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091326-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091326-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091326-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091326-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091326-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091326-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091326-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091326-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091326-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091326-002	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
naratriptan	NARATRIPTAN	ASCLEMED USA INC.	63ea356f-0895-4540-b242-8e611eacd938	2026-08-07	Warnings, Adverse reactions	Name fallback brand name: naratriptan
Naratriptan	NARATRIPTAN	Bionpharma Inc.	93b7e6c2-e6a7-4f6b-9ecd-62d6bb0a6dda	2026-06-30	Warnings, Adverse reactions	Name fallback brand name: Naratriptan
naratriptan	NARATRIPTAN	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	41c29652-32f8-48dc-9038-0e2195aa2084	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: naratriptan
Naratriptan	NARATRIPTAN	Hikma Pharmaceuticals USA Inc.	fd1944b3-8054-4faa-a82e-d818dfdd3875	2023-03-03	Warnings, Adverse reactions	Name fallback brand name: Naratriptan

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9332	ORIG	2010-07-12