FDA.reportPublic FDA data

Application 073025

Type
ANDA
Sponsor
HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATENOLOLATENOLOLTABLET;ORAL50MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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
2019-12-13 00:20 UTC2019-12A073025-001ATENOLOL50MGTABLET / ORALAB1991-09-1774a2ff9319b5…
2019-12-14 00:12 UTC2019-12A073025-001ATENOLOL50MGTABLET / ORALAB1991-09-173f01610625f2…
2019-09-15 20:21 UTC2019-09A073025-001ATENOLOL50MGTABLET / ORALAB1991-09-17b00525d2431f…
2019-07-19 19:46 UTC2019-07A073025-001ATENOLOL50MGTABLET / ORALAB1991-09-17ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A073025-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A073025-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A073025-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A073025-001AB1ea99ee380514…

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 5 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLAurobindo Pharma Limited1b8a4689-3916-4f4b-b54a-bbb4e322d79b2024-02-21Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLUnichem Pharmaceuticals (USA), Inc.35d99c43-7305-4a4a-886e-a9bf3ee88fa82024-01-18Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLZydus Pharmaceuticals USA Inc.db801706-1362-44c7-92ab-f584f96c7e1c2024-01-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLA-S Medication Solutionsd73a475a-c8c9-44a0-89ac-6a2d665c0d242023-12-26Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLA-S Medication Solutionsa0e3b2a5-5ea1-4549-8144-bd059f7966f02023-12-03Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLA-S Medication Solutions98471493-56ee-47a4-9120-0975c265361e2023-12-03Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
TENORMINATENOLOLAlmatica Pharma LLC746db603-a6e1-4dc3-c2d8-92314419098c2023-11-15Warnings, Adverse reactionsName fallback
generic name: ATENOLOL
AtenololATENOLOLNCS HealthCare of KY, LLC dba Vangard Labsc8cdb347-1767-4595-baff-b50987cd8c3a2023-02-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLC9aef7a49-d21f-4529-8abf-68bdc343bb6c2022-08-24Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLProficient Rx LP0a54656e-60dd-4ffc-b01a-423af19cd6182022-07-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLProficient Rx LP24f1f3f4-bbda-458b-b15f-d942c90534e22022-06-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLProficient Rx LPe115f27a-6a7c-498c-b4a1-2d4c5716af222020-10-01Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLBryant Ranch Prepackba0b0221-d4b3-4cb1-9435-53a75fcc4b402020-07-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLProficient Rx LPb198b34c-861a-4b52-b4df-8c48b807520a2020-02-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLProficient Rx LPc3a23869-1e3f-40f0-9726-8337005801132019-10-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLCb02b4be4-b75c-4153-b402-cf330a0774392017-12-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL

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 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1506AtenololAtenololSandoz IncANDACurrent
0781-1506AtenololAtenololSandoz IncANDACurrent
0781-5225AtenololAtenololSandoz IncANDACurrent
50090-2923AtenololAtenololA-S Medication SolutionsANDACurrent
50090-2923AtenololAtenololA-S Medication SolutionsANDACurrent
53808-1012AtenololAtenololState of Florida DOH Central PharmacyANDACurrent
55700-243AtenololAtenololLake Erie Medical DBA Quality Care Products LLCANDACurrent
62584-467AtenololAtenololAmerican Health PackagingANDACurrent
63187-201AtenololAtenololProficient Rx LPANDACurrent
63187-201AtenololAtenololProficient Rx LPANDACurrent
63629-6461AtenololAtenololBryant Ranch PrepackANDACurrent
63629-6461AtenololAtenololBryant Ranch PrepackANDACurrent
64205-506AtenololAtenololReadyMedsANDACurrent
67046-030AtenololAtenololContract Pharmacy Services-PAANDACurrent
67544-087AtenololAtenololAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-9236AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-9236AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0351AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0351AtenololAtenololREMEDYREPACK INC.ANDACurrent
71335-1355AtenololAtenololBryant Ranch PrepackANDACurrent
71335-1355AtenololAtenololBryant Ranch PrepackANDACurrent