FDA.reportPublic FDA data

Application 074052

Type
ANDA
Sponsor
HLTHCARE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATENOLOLATENOLOLTABLET;ORAL25MGNoNo

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 UTC2019-12A074052-001ATENOLOL25MGTABLET / ORALAB1992-05-0174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A074052-001ATENOLOL25MGTABLET / ORALAB1992-05-013f01610625f2…
2019-09-15 20:21 UTC2019-09A074052-001ATENOLOL25MGTABLET / ORALAB1992-05-01b00525d2431f…
2019-07-19 19:46 UTC2019-07A074052-001ATENOLOL25MGTABLET / ORALAB1992-05-01ea99ee380514…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A074052-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A074052-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074052-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074052-001AB1ea99ee380514…

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 3 of 5 · 96 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.95761173-1c95-46b2-a08f-fbc3e70daba82025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.8acdb229-928b-4c22-88f1-f4dd97cde2742025-10-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.c69b8e5e-c7c3-4883-9cea-f7f435a8ede82025-10-16Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLBryant Ranch Prepack290f4de3-8815-466c-81dc-8bc6323758962025-10-13Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.bdbf6779-8e9b-4ce1-a361-ede4914dd2f32025-10-08Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
TENORMINATENOLOLUpsher-Smith Laboratories, LLC6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a2025-09-18Warnings, Adverse reactionsName fallback
generic name: ATENOLOL
AtenololATENOLOLMylan Institutional Inc.8dd93a47-d14c-49be-9c22-97c0cdbec75a2025-07-18Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLA-S Medication Solutions3d35592c-91ac-44f6-b077-5963e952f0dd2025-07-16Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLA-S Medication Solutionsf419c72e-f1f9-4b5a-94ff-a525367cdce42025-07-16Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLA-S Medication Solutionsd3e72119-e3c3-41ba-8787-acc86b44d6c42025-05-29Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLA-S Medication Solutionsa3c8d507-e040-409e-9f97-742925cc66a12025-05-29Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLRising Pharma Holdings, Inc.96dd038f-b363-4e24-9c67-82b7c85c3bc42025-05-19Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLPreferred Pharmaceuticals Inc.0f744371-94fa-419d-bfed-b22301dde8b82025-02-21Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLNuCare Pharmaceuticals,Inc.8115a2bc-69aa-60b4-e053-2a91aa0aeae72025-02-06Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLMajor Pharmaceuticals4555261d-a997-4aa5-aba8-81aac70337872025-02-03Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
AtenololATENOLOLDirect_Rxee143f2f-be60-bc67-e053-2a95a90ae6e62025-01-22Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
ATENOLOLATENOLOLdirect rxb3d9f826-7ed7-1e3b-e053-2995a90ae7312025-01-17Warnings, Adverse reactionsName fallback
brand name: ATENOLOL
generic name: ATENOLOL
AtenololATENOLOLNuCare Pharmaceuticals,Inc.9db36b04-f353-55d6-e053-2a95a90ae08f2025-01-03Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Atenolol
generic name: ATENOLOL
Atenolol 29300-411ATENOLOLNuCare Pharmaceuticals,Inc.239b1cce-3b1a-f049-e063-6394a90a0e0a2024-12-26Warnings, Adverse reactionsName fallback
generic name: ATENOLOL
AtenololATENOLOLAmerican Health Packagingd19e9fcf-dfa1-43d7-94dc-e3f03fb90f5c2024-12-20Boxed 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 · 17 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-3544AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0781-1078AtenololAtenololSandoz IncANDACurrent
0781-1078AtenololAtenololSandoz IncANDACurrent
0781-5220AtenololAtenololSandoz IncANDACurrent
0904-5392AtenololAtenololMajor PharmaceuticalsANDACurrent
35356-930AtenololAtenololLake Erie Medical DBA Quality Care Products LLCANDACurrent
60760-256AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
64205-078AtenololAtenololReadyMedsANDACurrent
66267-030AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
66267-030AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
67544-161AtenololAtenololAphena Pharma Solutions - Tennessee, LLCANDACurrent
67544-161AtenololAtenololAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-7368AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-7368AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
70934-457AtenololAtenololDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-457AtenololAtenololDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
76413-140AtenololAtenololCentral Texas Community Health CentersANDACurrent