Application 062334
- Type
- ANDA
- Sponsor
- APOTHECON
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML | No | No |
| 002 | CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML | No | No |
| 003 | CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | FOR SUSPENSION;ORAL | EQ 500MG BASE/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062334-001 | CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | ||
| A062334-002 | CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | ||
| A062334-003 | CEFADROXIL | CEFADROXIL/CEFADROXIL HEMIHYDRATE | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062334-002 | CEFADROXIL | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062334-003 | CEFADROXIL | EQ 500MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062334-001 | CEFADROXIL | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | Approved before 1982 | 301d65b070ca… |
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 |
|---|---|---|---|---|---|---|
| Cefadroxil | CEFADROXIL | Proficient Rx LP | 57eebea5-28b6-44a3-888b-76950f6038f4 | 2026-06-01 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Redpharm Drug | 4fb524c1-f985-2a8f-e063-6394a90aab7f | 2026-04-18 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | REMEDYREPACK INC. | eb365f05-1c8f-4495-b443-abb0580b39fb | 2026-04-13 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Preferred Pharmaceuticals, Inc. | 485bc35b-637a-426b-aaa2-023c664914ae | 2026-03-24 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Preferred Pharmaceuticals Inc. | 41bc5f5a-5e1d-4cb6-a795-9f1756a8f074 | 2026-03-24 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | RedPharm Drug, Inc. | 97193a92-12ff-cfab-e053-2a95a90a9f14 | 2026-01-23 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Redpharm Drug | 1c50c0db-ca03-6217-e063-6294a90a89fa | 2025-12-25 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Redpharm Drug | 45ac01b1-b5b7-6fc1-e063-6394a90a271a | 2025-12-11 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | NuCare Pharmaceuticals,Inc. | 7e931c7e-5ab6-c39c-e053-2a91aa0a59d9 | 2025-11-19 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | PD-Rx Pharmaceuticals, Inc. | ab9cf28c-7c16-4bfa-879d-c360b4d1d5a6 | 2025-10-15 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Lupin Pharmaceuticals, Inc. | 5fe066ce-2f97-49d7-81bd-a672be1ebecd | 2025-10-10 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Lupin Pharmaceuticals, Inc. | 27009a05-4d2b-4618-be76-39f348240eda | 2025-10-08 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Bryant Ranch Prepack | caee9515-9a10-4020-af47-e9833aa69ef8 | 2025-06-20 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | PD-Rx Pharmaceuticals, Inc. | f5bbbf87-f059-4bbd-aea9-27d31462654f | 2025-02-28 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Direct_Rx | f6ddd84a-4a44-7035-e053-6294a90a6606 | 2025-01-22 | Warnings, Adverse reactions | Cefadroxil |
| CEFADROXIL | CEFADROXIL | DIRECT RX | a7e74b63-9d5c-7baa-e053-2a95a90a98b2 | 2025-01-17 | Warnings, Adverse reactions | CEFADROXIL |
| Cefadroxil | CEFADROXIL | Teva Pharmaceuticals USA, Inc. | bda86975-8c2f-4c4e-9a4c-a1a959f9336a | 2024-12-30 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Teva Pharmaceuticals USA, Inc. | 4674a05c-fdef-4737-a4b8-e3229bdada9d | 2024-12-30 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Advanced Rx of Tennessee, LLC | 205cb17b-6fbf-e147-e063-6294a90a608e | 2024-08-23 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Direct_Rx | 02566385-46f3-255a-e063-6294a90a1d1c | 2024-06-26 | Warnings, Adverse reactions | Cefadroxil |