FDA.reportPublic FDA data

Application 087127

Type
ANDA
Sponsor
AUREX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDETABLET;ORAL12.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2019-12-13 00:20 UTC2019-12A087127-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAAApproved before 198274a2ff9319b5…
2020-11-12 02:37 UTC2020-11A087127-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAAApproved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087127-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAAApproved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09A087127-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAAApproved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07A087127-001MECLIZINE HYDROCHLORIDE12.5MGTABLET / ORALAAApproved before 1982ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A087127-001AA174a2ff9319b5…
2020-11-12 02:37 UTC2020-11A087127-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A087127-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A087127-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A087127-001AA1ea99ee380514…

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 5 of 5 · 85 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEProficient Rx LPf574e123-8db7-4e3d-a0ee-e4e1f04ff1462022-06-01Warnings, Adverse reactionsName fallback
brand name: MECLIZINE HYDROCHLORIDE
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEProficient Rx LP91b1fd1a-1da2-4aae-826f-7de0bfe621612021-01-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Meclizine Hydrochloride
generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCLORIDEAsclemed USA, Inc.5c70e61b-a1e6-4981-92e2-1050cee08baa2020-10-30Warnings, Adverse reactionsName fallback
brand name: MECLIZINE HYDROCHLORIDE
Meclizine HydrochlorideMECLIZINE HYDROCHLORIDEEpic Pharma LLC467e464b-bbaf-4053-9136-39e47a92fa052020-08-21Warnings, Adverse reactionsName fallback
brand name: Meclizine Hydrochloride
generic name: MECLIZINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDEMECLIZINE HYDROCHLORIDEBryant Ranch Prepack53f410fd-104c-42c1-9740-6f48ffbc974f2020-05-22Warnings, Adverse reactionsName fallback
brand name: MECLIZINE HYDROCHLORIDE
generic name: MECLIZINE 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 · 6 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-1553Meclizine Hydrochloridemeclizine hydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
21695-383Meclizine HydrochlorideMeclizine HydrochlorideRebel Distributors Corp.ANDACurrent
49884-034Meclizine Hydrochloridemeclizine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
49884-034Meclizine Hydrochloridemeclizine hydrochloridePar Pharmaceutical, Inc.ANDACurrent
52959-225Meclizine Hydrochloridemeclizine hydrochlorideH.J. Harkins Company, Inc.ANDACurrent
60429-204Meclizine Hydrochloridemeclizine hydrochlorideGolden State Medical Supply, Inc.ANDACurrent