Application 076175

Type: ANDA
Sponsor: SANDOZ

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEFLOQUINE HYDROCHLORIDE	MEFLOQUINE HYDROCHLORIDE	TABLET;ORAL	250MG	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
A076175-001	MEFLOQUINE HYDROCHLORIDE	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB		2002-02-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076175-001	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	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	2002-02-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	2002-02-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	2002-02-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	2002-02-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	2002-02-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076175-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		2002-02-20	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A076175-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076175-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076175-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076175-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076175-001	AB	1	`6a471c1ec25d…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076175-001	AB	1	`a50c72e98297…`

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mefloquine Hydrochloride	MEFLOQUINE HYDROCHLORIDE	Chartwell RX, LLC	b884d22b-aae7-4f14-9a04-ae4029a229f0	2024-11-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076175 application number: ANDA076175

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
Document	Submission type	Date
39508	SUPPL	2013-07-29
39507	SUPPL	2012-05-16
18441	ORIG	2003-12-24
22542	ORIG	2003-08-04
31095	ORIG	2003-04-11