Home Applications 077877 Application 077877
Type ANDA
Sponsor IPCA LABS LTD Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 ATENOLOL ATENOLOL TABLET;ORAL 25MG No No 002 ATENOLOL ATENOLOL TABLET;ORAL 50MG No No 003 ATENOLOL ATENOLOL TABLET;ORAL 100MG No No
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A077877-001 ATENOLOL ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 A077877-002 ATENOLOL ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 A077877-003 ATENOLOL ATENOLOL 100MG TABLET / ORAL AB 2006-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077877-001 ATENOLOL 25MG TABLET / ORAL 2006-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077877-002 ATENOLOL 50MG TABLET / ORAL 2006-12-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077877-003 ATENOLOL 100MG TABLET / ORAL 2006-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077877-001 ATENOLOL 25MG TABLET / ORAL 2006-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077877-002 ATENOLOL 50MG TABLET / ORAL 2006-12-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A077877-003 ATENOLOL 100MG TABLET / ORAL 2006-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077877-001 ATENOLOL 25MG TABLET / ORAL 2006-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077877-002 ATENOLOL 50MG TABLET / ORAL 2006-12-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077877-003 ATENOLOL 100MG TABLET / ORAL 2006-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077877-001 ATENOLOL 25MG TABLET / ORAL 2006-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077877-002 ATENOLOL 50MG TABLET / ORAL 2006-12-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077877-003 ATENOLOL 100MG TABLET / ORAL 2006-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077877-001 ATENOLOL 25MG TABLET / ORAL 2006-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077877-002 ATENOLOL 50MG TABLET / ORAL 2006-12-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077877-003 ATENOLOL 100MG TABLET / ORAL 2006-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077877-002 ATENOLOL 50MG TABLET / ORAL AB 2006-12-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077877-003 ATENOLOL 100MG TABLET / ORAL AB 2006-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077877-001 ATENOLOL 25MG TABLET / ORAL AB 2006-12-27 8072bd15b7f6…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 108 observed states.
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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Atenolol ATENOLOL Ipca Laboratories Limited 98d29958-b026-4888-a516-7bb85bb7d479 2026-01-21 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 077877 application number: ANDA077877
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 42 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 10544-127 Atenolol Atenolol Blenheim Pharmacal, Inc. ANDA Current 10544-134 Atenolol Atenolol Blenheim Pharmacal, Inc. ANDA Current 10544-171 Atenolol Atenolol Blenheim Pharmacal, Inc. ANDA Current 12634-436 Atenolol Atenolol Apotheca Inc. ANDA Current 21695-322 Atenolol Atenolol Rebel Distributors Corp. ANDA Current 33261-220 Atenolol Atenolol Aidarex Pharmaceuticals LLC ANDA Current 33261-349 Atenolol Atenolol Aidarex Pharmaceuticals LLC ANDA Current 33261-517 Atenolol Atenolol Aidarex Pharmaceuticals LLC ANDA Current 42254-046 Atenolol Atenolol Rebel Distributors Corp ANDA Current 42254-107 Atenolol Atenolol Rebel Distributors Corp ANDA Current 51655-926 Atenolol Atenolol Northwind Pharmaceuticals, LLC ANDA Current 51655-927 ATENOLOL ATENOLOL Northwind Pharmaceuticals, LLC ANDA Current 52959-463 Atenolol Atenolol H.J. Harkins Company, Inc. ANDA Current 53808-0345 Atenolol Atenolol State of Florida DOH Central Pharmacy ANDA Current 53808-0346 Atenolol Atenolol State of Florida DOH Central Pharmacy ANDA Current 55289-227 Atenolol Atenolol PD-Rx Pharmaceuticals, Inc. ANDA Current 55289-228 Atenolol Atenolol PD-Rx Pharmaceuticals, Inc. ANDA Current 60760-059 Atenolol Atenolol St Marys Medical Park Pharmacy ANDA Current 61919-257 ATENOLOL ATENOLOL Direct Rx ANDA Current 61919-257 ATENOLOL ATENOLOL Direct Rx ANDA Current 61919-914 ATENOLOL ATENOLOL DIRECT RX ANDA Current 61919-914 ATENOLOL ATENOLOL DIRECT RX ANDA Current 61919-914 ATENOLOL ATENOLOL DIRECT RX ANDA Current 63187-092 Atenolol Atenolol Proficient Rx LP ANDA Current 63187-092 Atenolol Atenolol Proficient Rx LP ANDA Current 63304-621 Atenolol Atenolol Ranbaxy Pharmaceuticals Inc. ANDA Current 63304-622 Atenolol Atenolol Ranbaxy Pharmaceuticals Inc. ANDA Current 63304-623 Atenolol Atenolol Ranbaxy Pharmaceuticals Inc. ANDA Current 63629-1785 Atenolol Atenolol Bryant Ranch Prepack ANDA Current 63629-1785 Atenolol Atenolol Bryant Ranch Prepack ANDA Current 63629-2626 Atenolol Atenolol Bryant Ranch Prepack ANDA Current 63629-2626 Atenolol Atenolol Bryant Ranch Prepack ANDA Current 64725-0621 Atenolol Atenolol TYA Pharmaceuticals ANDA Current 66116-389 Atenolol Atenolol MedVantx, Inc. ANDA Current 67046-031 Atenolol atenolol Contract Pharmacy Services-PA ANDA Current 67296-0671 Atenolol Atenolol RedPharm Drug Inc. ANDA Current 67296-0674 Atenolol Atenolol RedPharm Drug Inc. ANDA Current 67296-0676 Atenolol Atenolol RedPharm Drug Inc. ANDA Current 67296-0755 Atenolol Atenolol RedPharm Drug Inc. ANDA Current 68788-9047 Atenolol Atenolol Preferred Pharmaceuticals, Inc. ANDA Current 68788-9048 Atenolol Atenolol Preferred Pharmaceuticals, Inc. ANDA Current 68788-9049 Atenolol Atenolol Preferred Pharmaceuticals, Inc. ANDA Current