Application 090288

Type: ANDA
Sponsor: CHARTWELL RX

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 44.

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
A090288-001	NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE	EQ 1MG BASE	TABLET / ORAL			2010-07-07
A090288-002	NARATRIPTAN	NARATRIPTAN HYDROCHLORIDE	EQ 2.5MG BASE	TABLET / ORAL			2010-07-07

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 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090288-001	NARATRIPTAN	EQ 1MG BASE	TABLET / ORAL	2010-07-07	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090288-002	NARATRIPTAN	EQ 2.5MG BASE	TABLET / ORAL	2010-07-07	`3a93d1ddd44b…`

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

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0781-5527	Naratriptan	Naratriptan	Sandoz Inc	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
9264	ORIG	2010-07-09