Application 019591

Type: NDA
Sponsor: ROCHE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	LARIAM	MEFLOQUINE HYDROCHLORIDE	TABLET;ORAL	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	Yes	No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 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
N019591-001	LARIAM	MEFLOQUINE HYDROCHLORIDE	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL		RLD	1989-05-02

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	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019591-001	LARIAM	250MG	TABLET / ORAL	RLD	1989-05-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019591-001	LARIAM	250MG	TABLET / ORAL	RLD	1989-05-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-05-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-05-02	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-05-02	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-05-02	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-05-02	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-05-02	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-05-02	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-05-02	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET / ORAL	RLD	1989-05-02	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N019591-001	LARIAM	250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	1989-05-02	`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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mefloquine Hydrochloride	MEFLOQUINE HYDROCHLORIDE	Teva Pharmaceuticals USA, Inc.	09716a24-d7da-42b2-af29-c03a1b6670bd	2025-09-26	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEFLOQUINE HYDROCHLORIDE
Mefloquine Hydrochloride	MEFLOQUINE HYDROCHLORIDE	A-S Medication Solutions	9cbe26c7-7313-4cd6-9514-9190af1de763	2025-04-03	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEFLOQUINE HYDROCHLORIDE
Mefloquine Hydrochloride	MEFLOQUINE HYDROCHLORIDE	Chartwell RX, LLC	b884d22b-aae7-4f14-9a04-ae4029a229f0	2024-11-18	Boxed warning, Warnings, Adverse reactions	Name fallback generic name: MEFLOQUINE HYDROCHLORIDE

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72422	SUPPL	2022-10-19
72421	SUPPL	2022-10-19
72420	SUPPL	2022-10-19
72419	SUPPL	2022-10-19
72418	SUPPL	2022-10-19
72417	SUPPL	2022-10-19
72416	SUPPL	2022-10-19
72413	SUPPL	2022-10-19
72412	SUPPL	2022-10-19
72313	SUPPL	2022-10-12
56374	SUPPL	2018-11-08
17472	SUPPL	2011-05-04
17471	SUPPL	2009-11-19
17469	SUPPL	2009-11-19
43622	ORIG	2009-09-25
11549	SUPPL	2009-09-17
11547	SUPPL	2009-09-17
11548	SUPPL	2009-07-24
17470	SUPPL	2009-06-30
33808	SUPPL	2008-10-03
33807	SUPPL	2008-10-03
17468	SUPPL	2008-09-26
1402	SUPPL	2008-09-26
11546	SUPPL	2008-06-05
17467	SUPPL	2008-05-14
11545	SUPPL	2003-09-08
11544	SUPPL	2003-09-08
1401	SUPPL	2003-09-08
17466	SUPPL	2003-07-10
33806	SUPPL	2003-07-09
33805	SUPPL	2003-01-10
33804	SUPPL	2003-01-10
17465	SUPPL	2003-01-10
1400	SUPPL	2003-01-10
11543	ORIG	2002-10-04