FDA.reportPublic FDA data

Application 071404

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORAZEPAMLORAZEPAMTABLET;ORAL1MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 6 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMHikma Pharmaceuticals USA Inc.5ff82103-cc57-4af9-9362-82a7c686271d2021-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLCe83ae439-3fa5-453f-9073-4bf8c797df472019-03-26Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLCa4fa14be-cef1-4b4b-b099-abde92f151452019-01-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMAphena Pharma Solutions - Tennessee, LLC08bd30b0-a1c1-4ec3-bb9c-b1d55ac59f752018-11-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM

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 · 19 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-5406LorazepamLorazepamSandoz IncANDACurrent
42254-254LorazepamLorazepamRebel Distributors CorpANDACurrent
45865-470LorazepamLorazepamMedsource PharmaceuticalsANDACurrent
52959-331LORAZEPAMLORAZEPAMH.J. Harkins Company, Inc.ANDACurrent
60760-457LorazepamLorazepamSt. MaryANDACurrent
61919-584LORAZEPAMLORAZEPAMDIRECT RXANDACurrent
63187-536LorazepamLorazepamProficient Rx LPANDACurrent
63187-536LorazepamLorazepamProficient Rx LPANDACurrent
63187-536LorazepamLorazepamProficient Rx LPANDACurrent
66267-427LorazepamLorazepamNuCare Pharmaceuticals, Inc.ANDACurrent
66267-835LorazepamLorazepamNuCare Pharmaceuticals, Inc.ANDACurrent
66267-835LorazepamLorazepamNuCare Pharmaceuticals, Inc.ANDACurrent
66336-047LorazepamLorazepamDispensing Solutions, Inc.ANDACurrent
67046-981LorazepamLorazepamContract Pharmacy Services-PAANDACurrent
67296-1539LorazepamLorazepamRedPharm Drug, Inc.ANDACurrent
67296-1539LorazepamLorazepamRedPharm Drug, Inc.ANDACurrent
68084-742LorazepamLorazepamAmerican Health PackagingANDACurrent
68788-9982LorazepamLorazepamPreferred Pharmaceuticals, Inc.ANDACurrent
71335-0204LorazepamLorazepamBryant Ranch PrepackANDACurrent