Application 062778
- Type
- ANDA
- Sponsor
- BARR
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEPHALEXIN | CEPHALEXIN | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A062778-001 | CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 |
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 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A062778-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 1987-08-06 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc. | 8073f183-e11f-41af-8bd1-1505bc7e044b | 2023-09-01 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| cephalexin | CEPHALEXIN | A-S Medication Solutions | 0a24b6e5-6f13-44b4-93f4-47c86945cad2 | 2023-04-26 | Warnings, Adverse reactions | cephalexin CEPHALEXIN |
| CEPHALEXIN | CEPHALEXIN | DIRECT RX | 2d12e6a9-f7dd-25ed-e054-00144ff8d46c | 2022-09-29 | Warnings, Adverse reactions | CEPHALEXIN CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc. | 6032b68f-16d8-41b6-bd2c-86d5406a757a | 2022-09-21 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc. | 891b8c0e-dbf4-4b0e-ba3f-c4c49d51510d | 2022-07-20 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Ascend Laboratories, LLC | bb28751c-bd1b-4e7f-8271-a14c1b4314e3 | 2022-07-07 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Proficient Rx LP | febab51b-6b48-488a-8fd1-d24400e5df1d | 2022-07-01 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Proficient Rx LP | dec3a1ef-1e85-4236-804b-e7a343d3a58f | 2022-05-02 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Proficient Rx LP | ada7b8a5-98f4-454c-b38f-92192d4db33f | 2021-08-01 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Teva Pharmaceuticals USA, Inc. | 19307ff0-71de-477b-965d-ea243e5ede3a | 2020-12-31 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Pharma-C, Inc. | bf9a6c06-11fd-4fb7-9cf5-e8e787758c1c | 2016-12-09 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.