Application 076392

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MEFLOQUINE HYDROCHLORIDE	MEFLOQUINE HYDROCHLORIDE	TABLET;ORAL	250MG	No	Yes

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
A076392-001	MEFLOQUINE HYDROCHLORIDE	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A076392-001	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		RS	2003-12-29	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		RS	2003-12-29	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		RS	2003-12-29	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL		RS	2003-12-29	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076392-001	MEFLOQUINE HYDROCHLORIDE	250MG	TABLET / ORAL	AB	RS	2003-12-29	`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	A076392-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A076392-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A076392-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076392-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076392-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076392-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076392-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076392-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076392-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076392-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076392-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076392-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076392-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076392-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076392-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076392-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076392-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076392-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076392-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076392-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076392-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076392-001	AB	1	`782e0a99824c…`
2019-12-14 00:12 UTC	2019-12	A076392-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076392-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076392-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076392-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076392-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076392-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076392-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076392-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076392-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076392-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076392-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076392-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076392-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076392-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076392-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076392-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A076392-001	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 · 2 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	Exact identifier application applno (ANDA): 076392 application number: ANDA076392 ndc (product): 0555-0171
Mefloquine Hydrochloride	MEFLOQUINE HYDROCHLORIDE	A-S Medication Solutions	9cbe26c7-7313-4cd6-9514-9190af1de763	2025-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076392 application number: ANDA076392 ndc (product): 50090-2396

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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0555-0171	Mefloquine Hydrochloride	Mefloquine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0171	Mefloquine Hydrochloride	Mefloquine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0171	Mefloquine Hydrochloride	Mefloquine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
0555-0171	Mefloquine Hydrochloride	Mefloquine Hydrochloride	Teva Pharmaceuticals USA, Inc.	ANDA	Current
21695-449	Mefloquine Hydrochloride	Mefloquine Hydrochloride	Rebel Distributors Corp	ANDA	Current
50090-2396	Mefloquine Hydrochloride	Mefloquine Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2396	Mefloquine Hydrochloride	Mefloquine Hydrochloride	A-S Medication Solutions	ANDA	Current
68071-4702	Mefloquine Hydrochloride	Mefloquine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68071-4702	Mefloquine Hydrochloride	Mefloquine Hydrochloride	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-6833	Mefloquine Hydrochloride	Mefloquine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6833	Mefloquine Hydrochloride	Mefloquine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-6833	Mefloquine Hydrochloride	Mefloquine Hydrochloride	Preferred Pharmaceuticals Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
18448	SUPPL	2013-07-29