Application 077443

Type
ANDA
Sponsor
UNIQUE PHARM LABS

Application Products#

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

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
A077443-001ATENOLOLATENOLOL25MGTABLET / ORALAB2006-09-13
A077443-002ATENOLOLATENOLOL50MGTABLET / ORALAB2006-09-13
A077443-003ATENOLOLATENOLOL100MGTABLET / ORALAB2006-09-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A077443-001AB
A077443-002AB
A077443-003AB

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 UTC2026-02A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-1331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-136a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-1303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-132680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-135bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-1379d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-13301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-002ATENOLOL50MGTABLET / ORALAB2006-09-131e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-003ATENOLOL100MGTABLET / ORALAB2006-09-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077443-001ATENOLOL25MGTABLET / ORALAB2006-09-138072bd15b7f6…

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 UTC2026-02A077443-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A077443-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A077443-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A077443-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A077443-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A077443-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A077443-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A077443-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A077443-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A077443-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A077443-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A077443-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A077443-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A077443-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A077443-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A077443-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A077443-001AB18072bd15b7f6…

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 2 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AtenololATENOLOLNuCare Pharmaceuticals,Inc.741f328d-21a1-3b19-e053-2a91aa0aa3272024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
ndc (product): 68071-4538
AtenololATENOLOLNuCare Pharmaceuticals,Inc.754a1ea1-1233-066f-e053-2991aa0a33a92024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
ndc (product): 68071-4553
AtenololATENOLOLNCS HealthCare of KY, LLC dba Vangard Labsc8cdb347-1767-4595-baff-b50987cd8c3a2023-02-23Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
ndc (product): 0615-8372
ndc (product): 0615-8373
AtenololATENOLOLProficient Rx LP0a54656e-60dd-4ffc-b01a-423af19cd6182022-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443
AtenololATENOLOLProficient Rx LPc3a23869-1e3f-40f0-9726-8337005801132019-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 077443
application number: ANDA077443

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 106 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-8372AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-8373AtenololAtenololNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
10544-167AtenololAtenololBlenheim Pharmacal, Inc.ANDACurrent
10544-586AtenololAtenololBlenheim Pharmacal, Inc.ANDACurrent
16571-430AtenololAtenololPack Pharmaceuticals LLCANDACurrent
16571-431AtenololAtenololPack Pharmaceuticals LLCANDACurrent
16571-441AtenololAtenololPack Pharmaceuticals LLCANDACurrent
42708-143AtenololAtenololQPharma IncANDACurrent
50090-5266AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5266AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5367AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5367AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5408AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5408AtenololAtenololA-S Medication SolutionsANDACurrent
50090-5408AtenololAtenololA-S Medication SolutionsANDACurrent
50436-0438AtenololAtenololUnit Dose ServicesANDACurrent
53002-2004AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-2138AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
53002-4108AtenololAtenololRPK Pharmaceuticals, Inc.ANDACurrent
55700-661AtenololAtenololLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-661AtenololAtenololLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-661AtenololAtenololLake Erie Medical DBA Quality Care Products LLCANDACurrent
55700-754AtenololAtenololQuality Care Products, LLCANDACurrent
55700-754AtenololAtenololQuality Care Products, LLCANDACurrent
55700-754AtenololAtenololQuality Care Products, LLCANDACurrent
55700-754AtenololAtenololQuality Care Products, LLCANDACurrent
55700-755AtenololAtenololQuality Care Products, LLCANDACurrent
55700-755AtenololAtenololQuality Care Products, LLCANDACurrent
55700-755AtenololAtenololQuality Care Products, LLCANDACurrent
55700-755AtenololAtenololQuality Care Products, LLCANDACurrent
60760-437AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
60760-437AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
60760-642AtenololAtenololSt Mary's Medical Park PharmacyANDACurrent
60760-642AtenololAtenololSt Mary's Medical Park PharmacyANDACurrent
60760-643AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
60760-643AtenololAtenololSt. Mary's Medical Park PharmacyANDACurrent
61919-854ATENOLOLATENOLOLDIRECT RXANDACurrent
61919-854ATENOLOLATENOLOLDirect_RxANDACurrent
61919-854ATENOLOLATENOLOLDirect_RxANDACurrent
64980-437AtenololAtenololRising Pharmaceuticals, Inc.ANDACurrent
64980-438AtenololAtenololRising Pharmaceuticals, Inc.ANDACurrent
64980-439AtenololAtenololRising Pharmaceuticals, Inc.ANDACurrent
67296-1726AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1726AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1732AtenololAtenololRedPharm Drug, Inc.ANDACurrent
67296-1732AtenololAtenololRedPharm Drug, Inc.ANDACurrent
68071-4527AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4527AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4527AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4527AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4538AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4538AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4538AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4538AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4553AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4553AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4751AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4751AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4751AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5162AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68071-5162AtenololAtenololNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7535AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7535AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7535AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7535AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7616AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7616AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
68788-7616AtenololAtenololPreferred Pharmaceuticals, Inc.ANDACurrent
70518-2866AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-2866AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-2939AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-2939AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-2939AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-2939AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-3007AtenololAtenololREMEDYREPACK INC.ANDACurrent
70518-3007AtenololAtenololREMEDYREPACK INC.ANDACurrent
70934-177AtenololAtenololDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-177AtenololAtenololDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-177AtenololAtenololDenton Pharma, Inc. DBA Northwind PharmaceuticalsANDACurrent
70934-177AtenololAtenololDenton Pharma, Inc. dba Northwind PharmaceuticalsANDACurrent