FDA.reportPublic FDA data

Application 203572

Type
ANDA
Sponsor
AUROLIFE PHARMA LLC

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
A203572-001LORAZEPAMLORAZEPAM0.5MGTABLET / ORALAB2017-12-22
A203572-002LORAZEPAMLORAZEPAM1MGTABLET / ORALAB2017-12-22
A203572-003LORAZEPAMLORAZEPAM2MGTABLET / ORALAB2017-12-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203572-001AB
A203572-002AB
A203572-003AB

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 22:54:322026-06A203572-001LORAZEPAM0.5MGTABLET / ORALAB2017-12-22a50c72e98297…
2026-08-01 22:54:322026-06A203572-002LORAZEPAM1MGTABLET / ORALAB2017-12-22a50c72e98297…
2026-08-01 22:54:322026-06A203572-003LORAZEPAM2MGTABLET / ORALAB2017-12-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A203572-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A203572-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A203572-003AB1a50c72e98297…

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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LORAZEPAMLORAZEPAMREMEDYREPACK INC.7fa1a011-5e28-4b13-bcd2-5c5fc9b663b22026-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LORAZEPAMLORAZEPAMBryant Ranch Prepack46af8e93-3169-408a-b4d8-b8498642801d2026-06-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 71335-1138
LorazepamLORAZEPAMPreferred Pharmaceuticals Inc.4a50329b-b272-4164-bddf-0d6cea3d7a232026-05-29Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 68788-7355
LorazepamLORAZEPAMBryant Ranch Prepack11372b3d-52c0-4694-8c88-4b72d3fda9d02026-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 71335-1694
LORAZEPAMLORAZEPAMPD-Rx Pharmaceuticals, Inc.0418ad09-3069-4381-9a8f-e41b234fdac62026-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LORAZEPAMLORAZEPAMAurolife Pharma LLC5b851f67-309d-4ef3-8b4b-ade8908256ea2025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 13107-084
ndc (product): 13107-083
ndc (product): 13107-085
LorazepamLORAZEPAMAmerican Health Packaging45e31a87-a8db-4dda-b94b-83535b62e8e22025-09-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMPreferred Pharmaceuticals, Inc.00960fbd-a5da-408b-9867-62982f20906f2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 68788-7428
LorazepamLORAZEPAMPreferred Pharmaceuticals, Inc.6cc1f35d-ff33-404e-aa5e-b01eab89863e2025-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 68788-7533
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8aaf9bcb-7a4e-ffaa-e053-2995a90a39132025-01-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 68071-4918
LORAZEPAMLORAZEPAMDirectRxddcc0b2b-4be2-6d18-e053-2a95a90af9872025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 72189-351
LORAZEPAMLORAZEPAMAdvanced Rx of Tennessee, LLC2a57e549-390b-5482-e063-6394a90aeb3b2024-12-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8fa33078-c379-41f5-e053-2995a90acced2024-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 68071-5022
LorazepamLORAZEPAMBryant Ranch Prepack853c762d-0772-4f02-99ca-0bc2911f09f02024-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 71335-1455
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.a4fe8df0-3ce8-b8b8-e053-2995a90a28f42024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 68071-5250
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.8aace309-f3ef-6aef-e053-2995a90aa1972024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 68071-4916
LorazepamLORAZEPAMNuCare Pharmaceuticals,Inc.933b5ef3-ec29-1a96-e053-2995a90a2d332024-06-19Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 68071-5068
LORAZEPAMLORAZEPAMA-S Medication Solutions8602cef8-167e-4a8c-b10f-fc3295a3abcc2024-01-21Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
LORAZEPAMLORAZEPAMAphena Pharma Solutions - Tennessee, LLC247110f2-5468-4593-8d86-41f8c869e03d2023-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572
ndc (product): 71610-229
LORAZEPAMLORAZEPAMA-S Medication Solutions823b1d71-a510-4d34-8015-60b55af23d782023-08-24Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203572
application number: ANDA203572

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 77 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
13107-083LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-083LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-083LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-083LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-083LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-084LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-084LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-084LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-084LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-084LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-085LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-085LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-085LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-085LorazepamLorazepamAurolife Pharma, LLCANDACurrent
13107-085LorazepamLorazepamAurolife Pharma, LLCANDACurrent
63629-8185LorazepamLorazepamBryant Ranch PrepackANDACurrent
63629-8185LorazepamLorazepamBryant Ranch PrepackANDACurrent
63629-8185LorazepamLorazepamBryant Ranch PrepackANDACurrent
63629-8223LorazepamLorazepamBryant Ranch PrepackANDACurrent
67046-888LorazepamLorazepamContract Pharmacy Services-PAANDACurrent
68071-4882LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4882LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4916LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4916LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4916LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4916LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4918LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4918LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5022LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5022LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5022LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5068LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5068LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5068LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5250LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5250LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5250LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5250LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5250LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5250LorazepamLorazepamNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7355LorazepamLorazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7355LorazepamLorazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7355LorazepamLorazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7355LorazepamLorazepamPreferred Pharmaceuticals Inc.ANDACurrent
68788-7428LorazepamLorazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7428LorazepamLorazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7428LorazepamLorazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7428LorazepamLorazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7533LorazepamLorazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7533LorazepamLorazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7533LorazepamLorazepamPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7533LorazepamLorazepamPreferred Pharmaceuticals, Inc.ANDACurrent
70934-782LorazepamLorazepamDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent
71205-228LorazepamLorazepamProficient Rx LPANDACurrent
71205-228LorazepamLorazepamProficient Rx LPANDACurrent
71205-228LorazepamLorazepamProficient Rx LPANDACurrent
71205-228LorazepamLorazepamProficient Rx LPANDACurrent
71205-228LorazepamLorazepamProficient Rx LPANDACurrent
71335-1138LorazepamLorazepamBryant Ranch PrepackANDACurrent
71335-1138LorazepamLorazepamBryant Ranch PrepackANDACurrent
71335-1138LorazepamLorazepamBryant Ranch PrepackANDACurrent
71335-1138LorazepamLorazepamBryant Ranch PrepackANDACurrent
71335-1138LorazepamLorazepamBryant Ranch PrepackANDACurrent
71335-1311LorazepamLorazepamBryant Ranch PrepackANDACurrent
71335-1311LorazepamLorazepamBryant Ranch PrepackANDACurrent
71335-1455LorazepamLorazepamBryant Ranch PrepackANDACurrent
71335-1455LorazepamLorazepamBryant Ranch PrepackANDACurrent
71335-1694LorazepamLorazepamBryant Ranch PrepackANDACurrent
71335-1694LorazepamLorazepamBryant Ranch PrepackANDACurrent
71335-1694LorazepamLorazepamBryant Ranch PrepackANDACurrent
71335-1694LorazepamLorazepamBryant Ranch PrepackANDACurrent
71610-199LorazepamLorazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-229LorazepamLorazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-600LorazepamLorazepamAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-351LORAZEPAMLORAZEPAMDirectRxANDACurrent
72189-351LORAZEPAMLORAZEPAMDirectRxANDACurrent
72189-351LORAZEPAMLORAZEPAMDirectRxANDACurrent