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| FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons* | Yes | No |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| FOR SUSPENSION;ORAL | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons* | Yes | No |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| KEFLEX | CEPHALEXIN | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | ||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| KEFLEX | CEPHALEXIN | EQ 250MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | ||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| KEFLEX | CEPHALEXIN | EQ 100MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons* | FOR SUSPENSION / ORAL | RLD, Approved before 1982 |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| N050406-001 | KEFLEX | EQ 125MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | FOR SUSPENSION / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||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 | Northwind Health Company, LLC | 4ecf9314-76e2-c270-e063-6294a90ad8db | 2026-09-03 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | c0ca008e-0e28-412e-a58f-70f63817713b | 2026-09-01 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Lupin Pharmaceuticals, Inc. | 1d3e6d33-5dc2-498e-8efa-e3c4fca15dff | 2026-08-24 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | HAWAII REPACK, INC. | d54abc0a-3c8f-4f02-bd55-406f0c5b925a | 2026-08-18 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Preferred Pharmaceuticals Inc. | 864d2046-b2c8-415c-814b-512bc4901c76 | 2026-08-12 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | c600a2c0-42ab-4be8-b9b1-59ba39494b3f | 2026-08-07 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | PD-Rx Pharmaceuticals, Inc. | af3e9919-3812-4917-bb6e-266a692ee4ab | 2026-08-07 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | PD-Rx Pharmaceuticals, Inc. | a24a3c7c-c0f8-4107-ab30-751bea743d2d | 2026-08-07 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | PD-Rx Pharmaceuticals, Inc. | 3dc725a0-6e4b-45c6-9569-34ef65455845 | 2026-08-07 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | PD-Rx Pharmaceuticals, Inc. | e4e1ebcf-b43b-4dbe-9295-eeef67ba6272 | 2026-08-07 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | b73593ce-0b1f-4371-bae1-140742de3b42 | 2026-08-06 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | d3527c0a-94e4-46a2-be77-d936abcd19ec | 2026-08-03 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | 2506895d-f3e0-4be9-95cb-7a6fd44de46d | 2026-08-03 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | AvKARE | 03f6f6ae-66bc-6819-8ba9-7c9c3fbef90d | 2026-07-29 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Preferred Pharmaceuticals Inc. | 88426cb3-1c0c-439b-9f1a-aa169040c29f | 2026-07-23 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | REMEDYREPACK INC. | a6b5edf2-1ef8-46b7-977a-8c303900f3f0 | 2026-07-22 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Aurobindo Pharma Limited | 655f38e8-1c4d-4cbc-9f52-bb881f065b2d | 2026-07-21 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 0384c418-b4d4-4c06-9ed9-13e864b1980b | 2026-07-16 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | d6954168-9c7f-4a6c-9262-2e6bed5c9f24 | 2026-07-14 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Bryant Ranch Prepack | 7508351d-69fe-457c-b450-9a2343be2587 | 2026-07-14 | Warnings, Adverse reactions | CEPHALEXIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.