Application 073457

Type
ANDA
Sponsor
MYLAN

Application Products#

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

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
A073457-001ATENOLOLATENOLOL100MGTABLET / ORALAB1992-01-24
A073457-002ATENOLOLATENOLOL25MGTABLET / ORALAB1999-04-26
A073457-003ATENOLOLATENOLOL50MGTABLET / ORALAB1992-01-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A073457-001AB
A073457-002AB
A073457-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-26d06236e962d9…
2024-10-29 15:01 UTC2024-10A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-2679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-26301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073457-002ATENOLOL25MGTABLET / ORALAB1999-04-261e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073457-003ATENOLOL50MGTABLET / ORALAB1992-01-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073457-001ATENOLOL100MGTABLET / ORALAB1992-01-248072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A073457-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073457-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A073457-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073457-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073457-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A073457-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A073457-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073457-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A073457-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073457-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073457-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A073457-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073457-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073457-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A073457-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073457-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073457-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A073457-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073457-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073457-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A073457-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073457-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073457-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A073457-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073457-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073457-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A073457-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A073457-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073457-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A073457-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073457-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073457-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A073457-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073457-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073457-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A073457-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073457-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073457-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A073457-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A073457-001AB18072bd15b7f6…

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLCardinal Health 107, LLC0fadc652-b075-46ec-ae05-beaf7d91ae132026-07-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLSafecor Health, LLC35d04cfd-34d4-429c-b990-a6c00137bc772026-07-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLGolden State Medical Supply, Inc.f4f06c00-9024-4e04-a882-0da2b24d8ff72026-06-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
ndc (product): 60429-027
ndc (product): 60429-026
ndc (product): 60429-025
AtenololATENOLOLCardinal Health 107, LLC15c0c2df-f195-45f9-a1e4-1ed2a43c22162026-04-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
ndc (product): 55154-5511
AtenololATENOLOLMylan Pharmaceuticals Inc.a7048c81-6769-436b-8397-fbaa7489fcdf2026-02-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
ndc (product): 0378-0218
ndc (product): 0378-0231
ndc (product): 0378-0757
AtenololATENOLOLNorthwind Health Company, LLCf318707a-4fb9-604c-e053-2a95a90ae9732026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLNorthwind Health Company, LLCd9cdc2ed-99bf-0d6a-e053-2a95a90a02622026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
AtenololATENOLOLMylan Institutional Inc.8dd93a47-d14c-49be-9c22-97c0cdbec75a2025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
ndc (product): 51079-759
ndc (product): 51079-685
ndc (product): 51079-684
ATENOLOLATENOLOLdirect rxb3d9f826-7ed7-1e3b-e053-2995a90ae7312025-01-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
ndc (product): 72189-146
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLC9aef7a49-d21f-4529-8abf-68bdc343bb6c2022-08-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
ndc (product): 71610-658
AtenololATENOLOLProficient Rx LPe115f27a-6a7c-498c-b4a1-2d4c5716af222020-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
ndc (product): 71205-496
AtenololATENOLOLAphena Pharma Solutions - Tennessee, LLCb02b4be4-b75c-4153-b402-cf330a0774392017-12-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 073457
application number: ANDA073457
ndc (product): 43353-834
ndc (product): 43353-986

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 83 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0378-0218AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0218AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0218AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0218AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0218AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0218AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0231AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0231AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0231AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0231AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0231AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0231AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0757AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0757AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0757AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0757AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0757AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0378-0757AtenololatenololMylan Pharmaceuticals Inc.ANDACurrent
0615-3532AtenololatenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-3533AtenololatenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
43353-834AtenololatenololAphena Pharma Solutions - Tennessee, LLCANDACurrent
43353-986AtenololatenololAphena Pharma Solutions - Tennessee, LLCANDACurrent
50090-2811AtenololatenololA-S Medication SolutionsANDACurrent
50090-5233AtenololatenololA-S Medication SolutionsANDACurrent
51079-684AtenololatenololMylan Institutional Inc.ANDACurrent
51079-684AtenololatenololMylan Institutional Inc.ANDACurrent
51079-684AtenololatenololMylan Institutional Inc.ANDACurrent
51079-684AtenololatenololMylan Institutional Inc.ANDACurrent
51079-684AtenololatenololMylan Institutional Inc.ANDACurrent
51079-684AtenololatenololMylan Institutional Inc.ANDACurrent
51079-685AtenololatenololMylan Institutional Inc.ANDACurrent
51079-685AtenololatenololMylan Institutional Inc.ANDACurrent
51079-685AtenololatenololMylan Institutional Inc.ANDACurrent
51079-685AtenololatenololMylan Institutional Inc.ANDACurrent
51079-685AtenololatenololMylan Institutional Inc.ANDACurrent
51079-685AtenololatenololMylan Institutional Inc.ANDACurrent
51079-759AtenololatenololMylan Institutional Inc.ANDACurrent
51079-759AtenololatenololMylan Institutional Inc.ANDACurrent
51079-759AtenololatenololMylan Institutional Inc.ANDACurrent
51079-759AtenololatenololMylan Institutional Inc.ANDACurrent
51079-759AtenololatenololMylan Institutional Inc.ANDACurrent
51079-759AtenololatenololMylan Institutional Inc.ANDACurrent
53808-1074AtenololatenololState of Florida DOH Central PharmacyANDACurrent
55154-5511AtenololatenololCardinal HealthANDACurrent
55154-5511AtenololatenololCardinal Health 107, LLCANDACurrent
55154-5511AtenololatenololCardinal HealthANDACurrent
55154-5511AtenololatenololCardinal Health 107, LLCANDACurrent
55154-5511AtenololatenololCardinal Health 107, LLCANDACurrent
55154-5511AtenololatenololCardinal HealthANDACurrent
55700-240AtenololatenololLake Erie Medical DBA Quality Care Products LLCANDACurrent
60429-025AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-025AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-025AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-025AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-025AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-025AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-026AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-026AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-026AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-026AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-026AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-026AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-027AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-027AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-027AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-027AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-027AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
60429-027AtenololatenololGolden State Medical Supply, Inc.ANDACurrent
67544-240AtenololatenololAphena Pharma Solutions - Tennessee, LLCANDACurrent
68788-7784AtenololatenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-7784AtenololatenololPreferred Pharmaceuticals Inc.ANDACurrent
68788-7784AtenololatenololPreferred Pharmaceuticals Inc.ANDACurrent
70518-1046AtenololatenololREMEDYREPACK INC.ANDACurrent
70518-1046AtenololatenololREMEDYREPACK INC.ANDACurrent
70518-1071AtenololatenololREMEDYREPACK INC.ANDACurrent
70518-1071AtenololatenololREMEDYREPACK INC.ANDACurrent
71205-496AtenololatenololProficient Rx LPANDACurrent
71610-658AtenololatenololAphena Pharma Solutions - Tennessee, LLCANDACurrent
71610-658AtenololatenololAphena Pharma Solutions - Tennessee, LLCANDACurrent
72189-146ATENOLOLATENOLOLdirect rxANDACurrent