Application 050406
- Type
- NDA
- Sponsor
- PRAGMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | KEFLEX | CEPHALEXIN | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | KEFLEX | CEPHALEXIN | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons* | Yes | No |
| 003 | KEFLEX | CEPHALEXIN | FOR SUSPENSION;ORAL | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons* | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050406-001 | KEFLEX | CEPHALEXIN | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | ||
| N050406-002 | KEFLEX | CEPHALEXIN | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | ||
| N050406-003 | KEFLEX | CEPHALEXIN | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 |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 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050406-002 | KEFLEX | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N050406-003 | KEFLEX | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, 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 |
|---|---|---|---|---|---|---|
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 980b9dd9-cb61-4c4f-81ac-85ee5a7c2497 | 2026-07-14 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 759c3856-8d3a-4036-926c-8508b573c736 | 2026-07-14 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 5b9b212a-3a3e-4637-b23c-6d66d8cf1171 | 2026-07-14 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 11cfefee-d75e-430c-8817-02dc57de0e88 | 2026-07-14 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 43ca66ae-2ada-412d-bc5d-f53602f535a5 | 2026-07-14 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | cf1c5d03-eddc-463a-84ad-4d59362c2cf8 | 2026-07-14 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Northwind Health Company, LLC | 1d0d50ba-8c2c-855c-e063-6394a90a5c7d | 2026-07-09 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Ascend Laboratories, LLC | 4fec8daf-6e09-4153-926f-64709dbdd26c | 2026-06-17 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | b3bb8222-161e-4d9c-8e08-7e22ad65bf72 | 2026-06-16 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | 8499aa5a-49b1-4555-bd27-6177d92b261d | 2026-06-09 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Unit Dose Solutions, Inc. | 53704ffd-b4f6-8b61-e063-6394a90a01f9 | 2026-06-04 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Proficient Rx LP | 7059a0b2-dd57-4fc1-ac3d-6aead35a4b08 | 2026-06-01 | Warnings, Adverse reactions | CEPHALEXIN |
| cephalexin | CEPHALEXIN | Lupin Pharmaceuticals, Inc. | 25ef498a-7a7e-4543-a544-b9d0e99f9cd9 | 2026-06-01 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Coupler LLC | 508a3401-df0b-0555-e063-6294a90a155a | 2026-04-28 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 47b6bc70-e8cc-4837-a39a-6998ee4e37dc | 2026-04-20 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 8a938dd0-fca6-4f22-9fb0-632596603001 | 2026-04-20 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 06c2fb2e-0539-4f16-bac4-e15a575ca802 | 2026-04-03 | Warnings, Adverse reactions | CEPHALEXIN |
| CEPHALEXIN | CEPHALEXIN | Direct_Rx | 90051655-77e9-6753-e053-2a95a90a462c | 2026-03-26 | Warnings, Adverse reactions | CEPHALEXIN |
| cephalexin | CEPHALEXIN | Preferred Pharmaceuticals Inc. | 553485f8-890d-4929-a6bb-905221cf411d | 2026-03-25 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Preferred Pharmaceuticlas Inc. | fbf5fcdf-40fc-40e5-b784-308032fff0e5 | 2026-03-25 | Warnings, Adverse reactions | CEPHALEXIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.