FDA.reportPublic FDA data

Application 087708

Type
ANDA
Sponsor
HIKMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDESOLUTION;ORAL0.025MG/5ML;2.5MG/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
A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRLD, RS1982-05-03

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 UTC2022-10A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRS1982-05-03cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A087708-001DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE0.025MG/5ML;2.5MG/5MLSOLUTION / ORALRLD, RS1982-05-03a50c72e98297…

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
Diphenoxylate Hydrochloride and Atropine SulfateDIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATEHikma Pharmaceuticals USA Inc.88ed4ccf-9e35-4142-a5eb-d2b5edd369562025-06-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 087708
application number: ANDA087708
ndc (product): 0054-3194

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 · 5 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0054-3194Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateWest-Ward Pharmaceuticals Corp.ANDACurrent
0054-3194Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateWest-Ward Pharmaceuticals Corp.ANDACurrent
17856-3194Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateAtlantic Biologicals CorpsANDACurrent
70166-630Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateLohxaANDACurrent
70166-630Diphenoxylate Hydrochloride and Atropine SulfateDiphenoxylate Hydrochloride and Atropine SulfateLohxaANDACurrent