Application 020259

Type: NDA
Sponsor: GLAXOSMITHKLINE LLC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEPRON	ATOVAQUONE	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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
N020259-001	MEPRON	ATOVAQUONE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1992-11-25

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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-11-25	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-11-25	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-11-25	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-11-25	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-11-25	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-11-25	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-11-25	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-11-25	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1992-11-25	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020259-001	MEPRON	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1992-11-25	`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 2 · 22 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Atovaquone Oral Suspension	ATOVAQUONE	KVK-Tech, Inc.	b31ff20a-c363-4be0-9bc0-3081c163b63c	2026-06-16	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
ATOVAQUONE	ATOVAQUONE	AvKARE	54423fee-da60-25dc-e063-6294a90a2552	2026-06-14	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	Camber Pharmaceuticals, Inc.	2445304e-4b4e-4358-b098-31f3c49c52ef	2026-06-10	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
atovaquone	ATOVAQUONE	Glenmark Pharmaceuticals Inc., USA	9045ba6f-938e-4717-bfa2-a3efe52f04cd	2026-05-06	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	PAI Holdings, LLC dba PAI Pharma	df6086d3-6100-422a-bf23-e9610027749b	2026-04-30	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
ATOVAQUONE	ATOVAQUONE	Amneal Pharmaceuticals LLC	b7398fcf-522a-488a-8dd6-051561f62804	2026-04-29	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
MEPRON	ATOVAQUONE	GlaxoSmithKline LLC	b426b6bf-f07e-4580-97ae-dfca1ddf5b8f	2026-03-20	Warnings, Adverse reactions	Name fallback brand name: MEPRON generic name: ATOVAQUONE
Atovaquone Oral Suspension	ATOVAQUONE	Kesin Pharma Corporation	4a2e2c4b-85aa-9b30-e063-6294a90a7bd9	2026-02-06	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	Golden State Medical Supply, Inc.	ddbfe1a9-df9b-79b0-e053-2995a90acc9b	2025-12-17	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	Bionpharma Inc.	bff4f4fc-6307-f414-e053-2a95a90ac0de	2025-12-04	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	Chartwell Governmental & Specialty RX, LLC.	e6770b85-54f8-4969-af02-7d81586be761	2025-11-07	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	American Health Packaging	1a8a43a2-bc26-4ee5-aa35-22a5477a7129	2025-10-17	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
ATOVAQUONE	ATOVAQUONE	AvPAK	4124ad97-f6b9-8afb-e063-6294a90ab970	2025-10-14	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	ATLANTIC BIOLOGICALS CORP.	40331de7-819e-5965-e063-6294a90ac91d	2025-10-01	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	Kesin Pharma	16b69156-e5de-c601-e063-6394a90afeae	2025-09-15	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	ATLANTIC BIOLOGICALS CORP.	f99a8a0c-2b42-4da0-8f5a-e963fc619e8b	2025-05-12	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	Abon Pharmaceuticals, LLC	2d3715ed-6ddc-4c10-9d2c-9c80cb1dfd08	2025-05-12	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	Lohxa	ba3cad0d-cce9-424f-ba5c-557dba8bef12	2025-03-20	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	A2A Integrated Pharmaceuticals, LLC	27d64592-5078-6122-e063-6394a90ae074	2025-01-02	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE
Atovaquone	ATOVAQUONE	Chartwell RX, LLC	de0e29b5-a4c7-405c-a5b9-438729d9ba3a	2024-05-24	Warnings, Adverse reactions	Name fallback generic name: ATOVAQUONE

Reported adverse events (FAERS/openFDA)#

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