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 42.

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 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-002ATENOLOL100MGTABLET / ORALAB1995-01-18301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-003ATENOLOL25MGTABLET / ORALAB2004-07-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074056-001ATENOLOL50MGTABLET / ORALAB1995-01-181e350fbaab3a…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 126 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074056-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074056-001AB11e350fbaab3a…

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
ndc (product): 42708-012
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.95761173-1c95-46b2-a08f-fbc3e70daba82025-10-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
ndc (product): 43063-805
AtenololATENOLOLPD-Rx Pharmaceuticals, Inc.c69b8e5e-c7c3-4883-9cea-f7f435a8ede82025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
ndc (product): 43063-765
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
AtenololATENOLOLTeva Pharmaceuticals USA, Inc.25a72ec9-de0f-44e5-90b8-da1aab0d35882024-05-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
ndc (product): 0093-0752
ndc (product): 0093-0787
ndc (product): 0093-0753
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
ndc (product): 63187-537
AtenololATENOLOLBryant Ranch Prepackba0b0221-d4b3-4cb1-9435-53a75fcc4b402020-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
AtenololATENOLOLProficient Rx LPb198b34c-861a-4b52-b4df-8c48b807520a2020-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074056
application number: ANDA074056
ndc (product): 63187-710

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 150 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0093-0752AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0752AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0752AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0752AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0753AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0753AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0753AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0753AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0787AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0787AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0787AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0093-0787AtenololAtenololTeva Pharmaceuticals USA, Inc.ANDACurrent
0615-8026AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8026AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8027AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8027AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
12634-604AtenololAtenololApotheca Inc.ANDACurrent
42291-140AtenololAtenololAvKARE, Inc.ANDACurrent
42291-141AtenololAtenololAvKARE, Inc.ANDACurrent
42291-142AtenololAtenololAvKARE, Inc.ANDACurrent
42708-012AtenololAtenololQPharma IncANDACurrent
42708-012AtenololAtenololQPharma IncANDACurrent
42708-012AtenololAtenololQPharma IncANDACurrent
43063-765AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-765AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-765AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-765AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-765AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-765AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, InANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-805AtenololAtenololPD-Rx Pharmaceuticals, Inc.ANDACurrent
43353-833AtenololAtenololAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-3043AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3043AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3043AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3071AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3410AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3410AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3410AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3410AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3411AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3411AtenololAtenololA-S Medication SolutionsANDACurrent
50090-3411AtenololAtenololA-S Medication SolutionsANDACurrent
50436-0752AtenololAtenololUnit Dose ServicesANDACurrent
50436-0753AtenololAtenololUnit Dose ServicesANDACurrent
53002-1004AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-1004AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-1108AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-1108AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-1138AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-1138AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53217-201AtenololAtenololAidarex Pharmaceuticals LLCANDACurrent
53217-237AtenololAtenololAidarex Pharmaceuticals LLCANDACurrent
60760-787AtenololAtenololSt Mary's Medical Park PharmacyANDACurrent
61919-279ATENOLOLATENOLOLDirectRXANDACurrent
61919-279ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-279ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-279ATENOLOLATENOLOLDirect_RxANDACurrent
61919-279ATENOLOLATENOLOLDirect_RxANDACurrent
61919-279ATENOLOLATENOLOLDirect_RxANDACurrent
61919-664ATENOLOLATENOLOLDirect_RxANDACurrent
61919-664ATENOLOLATENOLOLDirect_RxANDACurrent
61919-664ATENOLOLATENOLOLDirect_RxANDACurrent
61919-664ATENOLOLATENOLOLDirectRXANDACurrent
61919-664ATENOLOLATENOLOLDirect_RxANDACurrent
61919-664ATENOLOLATENOLOLDirect_RxANDACurrent
63187-537AtenololAtenololProficient Rx LPANDACurrent
63187-537AtenololAtenololProficient Rx LPANDACurrent
63187-537AtenololAtenololProficient Rx LPANDACurrent
63187-537AtenololAtenololProficient Rx LPANDACurrent
63187-710AtenololAtenololProficient Rx LPANDACurrent
63187-710AtenololAtenololProficient Rx LPANDACurrent
63187-710AtenololAtenololProficient Rx LPANDACurrent
63629-6443AtenololAtenololBryant Ranch PrepackANDACurrent
63629-6443AtenololAtenololBryant Ranch PrepackANDACurrent