FDA.reportPublic FDA data

Application 077754

Type
ANDA
Sponsor
OXFORD PHARMS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORAZEPAMLORAZEPAMTABLET;ORAL0.5MGNoNo
002LORAZEPAMLORAZEPAMTABLET;ORAL1MGNoNo
003LORAZEPAMLORAZEPAMTABLET;ORAL2MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A077754-001LORAZEPAMLORAZEPAM0.5MGTABLET / ORALAB2006-05-10
A077754-002LORAZEPAMLORAZEPAM1MGTABLET / ORALAB2006-05-10
A077754-003LORAZEPAMLORAZEPAM2MGTABLET / ORALAB2006-05-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A077754-001AB
A077754-002AB
A077754-003AB

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
2026-08-01 22:54:322026-06A077754-001LORAZEPAM0.5MGTABLET / ORALAB2006-05-10a50c72e98297…
2026-08-01 22:54:322026-06A077754-002LORAZEPAM1MGTABLET / ORALAB2006-05-10a50c72e98297…
2026-08-01 22:54:322026-06A077754-003LORAZEPAM2MGTABLET / ORALAB2006-05-10a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A077754-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A077754-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A077754-003AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 6 · 104 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LorazepamLORAZEPAMREMEDYREPACK INC.be9f8bda-1cd9-40a6-a4da-b5961389fb5b2026-07-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMREMEDYREPACK INC.6c5356b1-c199-49ad-bb00-fd67c6691f742026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMREMEDYREPACK INC.eb068a0f-5c0e-4218-b4c5-a0d0b1d362bd2026-07-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMANI Pharmaceuticals, Inc.787240e9-67b5-4af3-b16d-7cf314e3f2e32026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMHospira, Inc.20140b19-846b-425f-b191-670e178099452026-07-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMREMEDYREPACK INC.d6364be4-056b-4ebe-83bc-3fc85e8f488c2026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMSt. Mary's Medical Park Pharmacy56093df3-10f6-e747-e063-6294a90a65642026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMSt. Mary's Medical Park Pharmacy569e8a5a-ddf7-ebbc-e063-6294a90ab7a42026-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMREMEDYREPACK INC.b707ecb2-644c-4323-ab0e-7bc5929cd5602026-06-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMUnit Dose Solutions, Inc.5519bba8-9eb7-a3e0-e063-6294a90afd942026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMUnit Dose Solutions, Inc.551a1b7f-d342-2c53-e063-6394a90a9a2a2026-06-25Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMREMEDYREPACK INC.0cd02e52-ead5-4b2a-9708-c7c4be7b79952026-06-24Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMCoupler LLC54d72943-f8d1-5a78-e063-6294a90a059b2026-06-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMRedpharm Drug5407f327-3a22-8c15-e063-6294a90a31692026-06-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LORAZEPAMLORAZEPAMREMEDYREPACK INC.7fa1a011-5e28-4b13-bcd2-5c5fc9b663b22026-06-10Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LORAZEPAM
generic name: LORAZEPAM
LorazepamLORAZEPAMREMEDYREPACK INC.ac1f88c2-2cf2-47de-a612-946cd45030902026-06-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LORAZEPAMLORAZEPAMBryant Ranch Prepack46af8e93-3169-408a-b4d8-b8498642801d2026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: LORAZEPAM
generic name: LORAZEPAM
LorazepamLORAZEPAMREMEDYREPACK INC.5a02c97d-637d-43f7-803c-afe4381ccc592026-06-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMPreferred Pharmaceuticals Inc.4a50329b-b272-4164-bddf-0d6cea3d7a232026-05-29Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM
LorazepamLORAZEPAMRedpharm Drug52614947-c96c-3361-e063-6394a90ae1722026-05-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Lorazepam
generic name: LORAZEPAM

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
0603-4246LorazepamlorazepamQualitest PharmaceuticalsANDACurrent
0615-8003LorazepamlorazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8004LorazepamLorazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8050LorazepamLorazepamNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
67296-1060LorazepamLorazepamRedPharm Drug, Inc.ANDACurrent
67296-1060LorazepamLorazepamRedPharm Drug, Inc.ANDACurrent