FDA.reportPublic FDA data

Application 077699

Type
ANDA
Sponsor
HIKMA INTL PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEFLOQUINE HYDROCHLORIDEMEFLOQUINE HYDROCHLORIDETABLET;ORAL250MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077699-001MEFLOQUINE HYDROCHLORIDEMEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A077699-001MEFLOQUINE HYDROCHLORIDE250MGTABLET / ORAL2010-04-21a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mefloquine HydrochlorideMEFLOQUINE HYDROCHLORIDETeva Pharmaceuticals USA, Inc.09716a24-d7da-42b2-af29-c03a1b6670bd2025-09-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mefloquine Hydrochloride
generic name: MEFLOQUINE HYDROCHLORIDE
Mefloquine HydrochlorideMEFLOQUINE HYDROCHLORIDEA-S Medication Solutions9cbe26c7-7313-4cd6-9514-9190af1de7632025-04-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mefloquine Hydrochloride
generic name: MEFLOQUINE HYDROCHLORIDE
Mefloquine HydrochlorideMEFLOQUINE HYDROCHLORIDEChartwell RX, LLCb884d22b-aae7-4f14-9a04-ae4029a229f02024-11-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Mefloquine Hydrochloride
generic name: MEFLOQUINE HYDROCHLORIDE

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 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0143-1282Mefloquine HydrochlorideMefloquine HydrochlorideWest-Ward Pharmaceuticals CorpANDACurrent
21695-561Mefloquine HydrochlorideMefloquine HydrochlorideRebel Distributors CorpANDACurrent
52959-803Mefloquine HydrochlorideMefloquine HydrochlorideH.J. Harkins Company, Inc.ANDACurrent