Application 090872

Type: ANDA
Sponsor: MYLAN

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SUMATRIPTAN AND NAPROXEN SODIUM	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	TABLET;ORAL	500MG;EQ 85MG BASE	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE	500MG;EQ 85MG BASE	TABLET / ORAL	AB		2018-09-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090872-001	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 2 · 43 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
2026-09-14 22:38:34	2026-08	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090872-001	SUMATRIPTAN AND NAPROXEN SODIUM	500MG;EQ 85MG BASE	TABLET / ORAL	AB	2018-09-04	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A090872-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A090872-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090872-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090872-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090872-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090872-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090872-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090872-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090872-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090872-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090872-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090872-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090872-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090872-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090872-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090872-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090872-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090872-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090872-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090872-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090872-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090872-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090872-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090872-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090872-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090872-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090872-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090872-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090872-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090872-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090872-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090872-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090872-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090872-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090872-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090872-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090872-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090872-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090872-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090872-001	AB	1	`f41ea6bd6efb…`

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
Sumatriptan and Naproxen Sodium	SUMATRIPTAN AND NAPROXEN SODIUM	NorthStar RxLLC	3f2ec27e-0e96-4028-a1fa-114e6d501464	2025-11-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sumatriptan and Naproxen Sodium
Sumatriptan and Naproxen Sodium	SUMATRIPTAN AND NAPROXEN SODIUM	Sun Pharmaceutical Industries, Inc.	96ed12a3-fa76-4afd-bee8-1ab19eb607f3	2025-10-30	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sumatriptan and Naproxen Sodium
Sumatriptan and Naproxen Sodium	SUMATRIPTAN AND NAPROXEN SODIUM	Aurobindo Pharma Limited	f5203c66-0a40-4263-a237-b71e930e4697	2024-12-05	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Sumatriptan and Naproxen Sodium

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 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0378-8755	Sumatriptan and Naproxen Sodium	sumatriptan and naproxen sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8755	Sumatriptan and Naproxen Sodium	sumatriptan and naproxen sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8755	Sumatriptan and Naproxen Sodium	sumatriptan and naproxen sodium	Mylan Pharmaceuticals Inc.	ANDA	Current
0378-8755	Sumatriptan and Naproxen Sodium	sumatriptan and naproxen sodium	Mylan Pharmaceuticals Inc.	ANDA	Current