Application 074056

Type
ANDA
Sponsor
TEVA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ATENOLOLATENOLOLTABLET;ORAL50MGNoNo
002ATENOLOLATENOLOLTABLET;ORAL100MGNoNo
003ATENOLOLATENOLOLTABLET;ORAL25MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A074056-001ATENOLOLATENOLOL50MGTABLET / ORALAB1995-01-18
A074056-002ATENOLOLATENOLOL100MGTABLET / ORALAB1995-01-18
A074056-003ATENOLOLATENOLOL25MGTABLET / ORALAB2004-07-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A074056-001AB
A074056-002AB
A074056-003AB

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.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1884e616aacf4f…
2026-09-14 22:38:342026-08A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1984e616aacf4f…
2026-08-18 06:07:402026-07A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18caaa826d4ba7…
2026-08-18 06:07:402026-07A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-186a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-182680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-185bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-1879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-18301d65b070ca…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A074056-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A074056-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A074056-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A074056-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074056-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A074056-003AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074056-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074056-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074056-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074056-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074056-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074056-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074056-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074056-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074056-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074056-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074056-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074056-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074056-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074056-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-001AB1301d65b070ca…

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 1 of 1 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLQPharma, Inc.70d7a585-7a46-4eac-b2b5-2ac5b98d98822025-12-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.95761173-1c95-46b2-a08f-fbc3e70daba82025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.c69b8e5e-c7c3-4883-9cea-f7f435a8ede82025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLC23e96396-85d3-0d8e-e063-6394a90a614d2024-10-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLC247569d6-9a73-f1d0-e063-6394a90a667a2024-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLNuCare Pharmaceuticals,Inc.7366c6f8-4cb3-520e-e053-2991aa0a2cc82024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
ndc (product): 68071-4526
AtenololATENOLOLTeva Pharmaceuticals USA, Inc.25a72ec9-de0f-44e5-90b8-da1aab0d35882024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLA-S Medication Solutionsd73a475a-c8c9-44a0-89ac-6a2d665c0d242023-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLProficient Rx LP24f1f3f4-bbda-458b-b15f-d942c90534e22022-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLBryant Ranch Prepackba0b0221-d4b3-4cb1-9435-53a75fcc4b402020-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
ndc (product): 71335-1616
AtenololATENOLOLProficient Rx LPb198b34c-861a-4b52-b4df-8c48b807520a2020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056

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 2 of 2 · 150 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-6482AtenololAtenololBryant Ranch PrepackANDACurrent
63629-6482AtenololAtenololBryant Ranch PrepackANDACurrent
63629-8029AtenololAtenololBryant Ranch PrepackANDACurrent
63629-8030AtenololAtenololBryant Ranch PrepackANDACurrent
63629-8030AtenololAtenololBryant Ranch PrepackANDACurrent
63629-8030AtenololAtenololBryant Ranch PrepackANDACurrent
66116-437AtenololAtenololMedVantx, Inc.ANDACurrent
67046-032AtenololAtenololContract Pharmacy Services-PAANDACurrent
67296-1201AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1201AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1201AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1270AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1270AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1270AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1288AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1288AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1288AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67544-326AtenololAtenololAphena Pharma Solutions - Tennessee, LLCANDACurrent
68071-1771AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1771AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1771AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
68071-1772AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-1772AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-3320AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
68071-3335AtenololAtenololNuCare Pharmaceuticals, Inc.ANDACurrent
68071-4274AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4274AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4274AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4526AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4526AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4766AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4766AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5033AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5033AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68645-585AtenololAtenololLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-585AtenololAtenololLegacy Pharmaceutical Packaging, LLCANDACurrent
68645-585AtenololAtenololLegacy Pharmaceutical Packaging, LLCANDACurrent
68788-6450AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-6450AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-7496AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-7496AtenololAtenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-7528AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7528AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7528AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7528AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
70518-0147AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0379AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0379AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0379AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0379AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0399AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0399AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0399AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0399AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0882AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0882AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0882AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0882AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0882AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-0882AtenololAtenololREMEDYREPACK INC.ANDACurrent
70934-463AtenololAtenololDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-463AtenololAtenololDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
71335-0668AtenololAtenololBryant Ranch PrepackANDACurrent
71335-0668AtenololAtenololBryant Ranch PrepackANDACurrent
71335-0668AtenololAtenololBryant Ranch PrepackANDACurrent
71335-0988AtenololAtenololBryant Ranch PrepackANDACurrent
71335-0988AtenololAtenololBryant Ranch PrepackANDACurrent
71335-1108AtenololAtenololBryant Ranch PrepackANDACurrent
71335-1108AtenololAtenololBryant Ranch PrepackANDACurrent
71335-1616AtenololAtenololBryant Ranch PrepackANDACurrent