Application 078254
- Type
- ANDA
- Sponsor
- NORTHSTAR HLTHCARE
Application Products#
| 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 |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078254-001 | ATENOLOL | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | ||
| A078254-002 | ATENOLOL | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | ||
| A078254-003 | ATENOLOL | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 |
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.
| 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 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078254-002 | ATENOLOL | 50MG | TABLET / ORAL | 2009-09-25 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A078254-003 | ATENOLOL | 100MG | TABLET / ORAL | 2009-09-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A078254-001 | ATENOLOL | 25MG | TABLET / ORAL | 2009-09-25 | 8072bd15b7f6… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Atenolol | ATENOLOL | Cardinal Health 107, LLC | 0fadc652-b075-46ec-ae05-beaf7d91ae13 | 2026-07-20 | Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | Safecor Health, LLC | 35d04cfd-34d4-429c-b990-a6c00137bc77 | 2026-07-10 | Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | St. Mary's Medical Park Pharmacy | 7f8304a4-93de-774f-e053-2a91aa0aa5b5 | 2026-06-20 | Boxed warning, Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | Golden State Medical Supply, Inc. | f4f06c00-9024-4e04-a882-0da2b24d8ff7 | 2026-06-17 | Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | St Mary's Medical Park Pharmacy | 78d394b8-8ffb-a846-e053-2991aa0aa58c | 2026-06-17 | Boxed warning, Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | St. Mary's Medical Park Pharmacy | 8501f6c1-8157-4189-e053-2a91aa0ac4ef | 2026-06-02 | Boxed warning, Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | ASCLEMED USA INC. | 2ee7b7da-303d-4a57-a1eb-25e8923660c0 | 2026-05-19 | Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | Coupler LLC | 5126a70e-632d-e626-e063-6394a90ab791 | 2026-05-06 | Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | Coupler LLC | 50760735-9305-0bbf-e063-6294a90a5b4c | 2026-04-27 | Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | Coupler LLC | 50762eee-e139-4d7f-e063-6294a90a777c | 2026-04-27 | Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | Preferred Pharmaceuticals Inc. | 0ad0c7dd-e4e5-4968-9372-7a9bb30073ec | 2026-04-22 | Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | REMEDYREPACK INC. | f5c86a73-70b6-46b2-ad9a-272c8d4673e9 | 2026-04-13 | Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | Cardinal Health 107, LLC | 15c0c2df-f195-45f9-a1e4-1ed2a43c2216 | 2026-04-10 | Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | Preferred Pharmaceuticals Inc. | 5ad1426a-5a74-427b-812d-c7b144c84474 | 2026-03-10 | Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | Preferred Pharmaceuticals, Inc. | 26d3df38-20c6-40e0-a456-da4f10fff632 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | Preferred Pharmaceuticals, Inc. | a8d48a47-ccab-4a35-a092-6e562683ade3 | 2026-03-10 | Boxed warning, Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | Preferred Pharmaceuticals Inc. | 82100fc8-5a5a-4d80-8101-72024ee0abef | 2026-03-09 | Boxed warning, Warnings, Adverse reactions | Atenolol ATENOLOL |
| atenolol | ATENOLOL | direct rx | b3c757de-1cbf-61f5-e053-2995a90accfc | 2026-03-06 | Boxed warning, Warnings, Adverse reactions | atenolol ATENOLOL |
| Atenolol | ATENOLOL | A-S Medication Solutions | b6fe1a12-a6d5-4c4c-9d77-6f717b43f8fe | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | Atenolol ATENOLOL |
| Atenolol | ATENOLOL | A-S Medication Solutions | d21f2b4d-6584-48e5-8045-e5927ba03329 | 2026-02-20 | Boxed warning, Warnings, Adverse reactions | Atenolol ATENOLOL |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 66116-401 | Atenolol | Atenolol | MedVantx, Inc. | ANDA | Current |