Application 090359

Type: ANDA
Sponsor: BRECKENRIDGE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEFENAMIC ACID	MEFENAMIC ACID	CAPSULE;ORAL	250MG	No	No

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

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
A090359-001	MEFENAMIC ACID	MEFENAMIC ACID	250MG	CAPSULE / ORAL			2013-02-05

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090359-001	MEFENAMIC ACID	250MG	CAPSULE / ORAL	2013-02-05	`e64feba35796…`

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mefenamic Acid	MEFENAMIC ACID	Lupin Pharmaceuticals, Inc.	d15733a9-d5fd-4d5f-86ce-e7ed8c706c7f	2026-04-20	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mefenamic Acid generic name: MEFENAMIC ACID
Mefenamic acid	MEFENAMIC ACID	Bryant Ranch Prepack	9b8b3e03-4801-4ae8-b44e-e01d1ab1e34b	2026-03-17	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mefenamic acid generic name: MEFENAMIC ACID
Mefenamic Acid	MEFENAMIC ACID	Misemer Pharmaceuticals, Inc	d0291319-ab3e-20c8-e053-2a95a90afabb	2026-02-26	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mefenamic Acid generic name: MEFENAMIC ACID
Mefenamic acid	MEFENAMIC ACID	Micro Labs Limited	4b0788cd-bdca-4fa5-9eba-01a270613aab	2026-01-12	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mefenamic acid generic name: MEFENAMIC ACID
Mefenamic Acid	MEFENAMIC ACID	Advanced Rx Pharmacy of Tennessee, LLC	f8b1a4a2-83fc-6b4b-e053-6394a90ac46a	2024-12-31	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mefenamic Acid generic name: MEFENAMIC ACID
Mefenamic Acid	MEFENAMIC ACID	Advanced Rx of Tennessee, LLC	1e927779-411a-b5f5-e063-6394a90aae93	2024-07-19	Boxed warning, Warnings, Adverse reactions	Name fallback brand name: Mefenamic Acid generic name: MEFENAMIC ACID

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
51991-839	Mefenamic Acid	Mefenamic Acid	Breckenridge Pharmaceutical, Inc.	ANDA	Current