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 | NuCare Pharmaceuticals,Inc. | a218d8d3-af90-4599-e053-2995a90a0ede | 2024-06-20 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | NuCare Pharmaceuticals,Inc. | 8bdd68a4-4e2e-0170-e053-2a95a90adb78 | 2024-06-18 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | NuCare Pharmaceuticals,Inc. | 7278a39f-9de1-c9e2-e053-2a91aa0aea34 | 2024-06-10 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Advanced Rx Pharmacy of Tennessee, LLC | 1a50b564-b00f-58e4-e063-6294a90af2c6 | 2024-06-07 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | NuCare Pharmaceuticals,Inc. | 16f3dd01-650a-2426-e063-6394a90a1b4b | 2024-04-25 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Bryant Ranch Prepack | 672519a7-11a1-4d8e-b2ca-dc9598c2f179 | 2024-04-03 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Bryant Ranch Prepack | 9c3bed82-6df0-4643-944a-a826f7dc018f | 2024-04-03 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Bryant Ranch Prepack | 8cdaac56-b84a-4b6b-b94d-cab15d5961c5 | 2024-04-03 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | A-S Medication Solutions | 41ab333a-fafb-4647-844e-f3b2a76723cb | 2024-02-15 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Advanced Rx Pharmacy of Tennessee, LLC | ec836a53-7ed1-79b9-e053-2a95a90a9c36 | 2024-02-09 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | NorthStar Rx LLC | 30bb3686-87b4-4676-9ff5-e20deb8bff9d | 2024-02-09 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Rising Pharma Holdings, Inc. | 6e4111d3-f11b-403c-b340-b216022709df | 2024-02-09 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Aurobindo Pharma Limited | 776a8dbc-e68e-4732-acf4-0133dca0f54c | 2024-02-09 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Rising Pharma Holdings, Inc. | 74c99fd8-16d1-4d2c-9158-42ff5eed2b7c | 2024-01-30 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | Aurobindo Pharma Limited | 7bb90096-14d3-400e-94d3-048bff6b1292 | 2024-01-30 | Warnings, Adverse reactions | Cefadroxil |
| Cefadroxil | CEFADROXIL | NorthStar Rx LLC | 17123057-58c7-401a-b87d-8c4c0764bbf6 | 2024-01-30 | Warnings, Adverse reactions | Cefadroxil |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.