FDA.reportPublic FDA data

Application 088744

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDESYRUP;ORAL50MG/5MLNoYes

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
A088744-001MEPERIDINE HYDROCHLORIDEMEPERIDINE HYDROCHLORIDE50MG/5MLSYRUP / ORALRS1985-01-30

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 UTC2022-10A088744-001MEPERIDINE HYDROCHLORIDE50MG/5MLSYRUP / ORALRS1985-01-30f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A088744-001MEPERIDINE HYDROCHLORIDE50MG/5MLSYRUP / ORALRS1985-01-30e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A088744-001MEPERIDINE HYDROCHLORIDE50MG/5MLSYRUP / ORALRS1985-01-30cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A088744-001MEPERIDINE HYDROCHLORIDE50MG/5MLSYRUP / ORALRS1985-01-30a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meperidine HydrochlorideMEPERIDINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.15bc51a8-1e24-4d33-9a2f-05a41c29acf02026-02-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 088744
application number: ANDA088744
ndc (product): 0054-3545

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3545Meperidine HydrochlorideMeperidine HydrochlorideWest-Ward Pharmaceuticals Corp.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76205ORIG 2023-11-03