Application 050405
- Type
- NDA
- Sponsor
- PRAGMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 002 | KEFLEX | CEPHALEXIN | CAPSULE;ORAL | EQ 250MG BASE | Yes | No |
| 003 | KEFLEX | CEPHALEXIN | CAPSULE;ORAL | EQ 500MG BASE | Yes | No |
| 004 | KEFLEX | CEPHALEXIN | CAPSULE;ORAL | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | KEFLEX | CEPHALEXIN | CAPSULE;ORAL | EQ 750MG BASE | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N050405-002 | KEFLEX | CEPHALEXIN | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||
| N050405-003 | KEFLEX | CEPHALEXIN | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | ||
| N050405-004 | KEFLEX | CEPHALEXIN | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | |
| N050405-005 | KEFLEX | CEPHALEXIN | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 |
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| 2026-08 | N050405-002 | KEFLEX | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050405-003 | KEFLEX | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N050405-004 | KEFLEX | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N050405-005 | KEFLEX | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N050405-002 | KEFLEX | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050405-003 | KEFLEX | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N050405-004 | KEFLEX | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N050405-005 | KEFLEX | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050405-002 | KEFLEX | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050405-003 | KEFLEX | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N050405-004 | KEFLEX | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N050405-005 | KEFLEX | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050405-002 | KEFLEX | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050405-003 | KEFLEX | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050405-004 | KEFLEX | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N050405-005 | KEFLEX | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050405-002 | KEFLEX | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050405-003 | KEFLEX | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N050405-004 | KEFLEX | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N050405-005 | KEFLEX | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050405-002 | KEFLEX | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050405-003 | KEFLEX | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050405-004 | KEFLEX | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N050405-005 | KEFLEX | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050405-002 | KEFLEX | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050405-003 | KEFLEX | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050405-004 | KEFLEX | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N050405-005 | KEFLEX | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050405-002 | KEFLEX | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050405-003 | KEFLEX | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050405-004 | KEFLEX | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N050405-005 | KEFLEX | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050405-002 | KEFLEX | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050405-003 | KEFLEX | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050405-004 | KEFLEX | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N050405-005 | KEFLEX | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050405-002 | KEFLEX | EQ 250MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050405-003 | KEFLEX | EQ 500MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD, Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050405-004 | KEFLEX | EQ 333MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N050405-005 | KEFLEX | EQ 750MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | RLD | 2006-05-12 | 5bbf6a4d5a75… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N050405-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050405-003 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | N050405-005 | AB | 1 | 74a2ff9319b5… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050405-002 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050405-003 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N050405-005 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | N050405-002 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N050405-003 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | N050405-005 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | N050405-002 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N050405-003 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | N050405-005 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | N050405-002 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N050405-003 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | N050405-005 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | N050405-002 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N050405-003 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | N050405-005 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N050405-002 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N050405-003 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | N050405-005 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N050405-002 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N050405-003 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N050405-005 | AB | 1 | ea99ee380514… |
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 | f4ced8c7-a276-4a44-a60c-f8d1689a2bdf | 2024-07-26 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 6e5f9616-ddf2-19c4-e053-2991aa0a372a | 2024-07-18 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | ada33464-b416-9ac6-e053-2a95a90af787 | 2024-07-17 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | ade02343-3e4b-b1f1-e053-2995a90ac5fe | 2024-07-17 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | a33280d4-7caf-f74b-e053-2a95a90a90c3 | 2024-07-17 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc | 945552cb-90e4-41fb-afe2-8ee8785e94da | 2024-07-17 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 3fcb3f88-9dfc-444d-952a-1d1967720525 | 2024-06-28 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc. | 4eb58a7e-1c92-4be3-b702-e522e0fbf425 | 2024-06-21 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc. | 20f8cc57-231c-4d36-a209-ff9e5735d65c | 2024-06-20 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 90a76d24-e5a9-9000-e053-2a95a90ae8af | 2024-06-19 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e | 2024-06-10 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 6be20569-df34-04d9-e053-2991aa0a94fd | 2024-06-10 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 728c5212-dbd8-8df5-e053-2a91aa0a9579 | 2024-06-10 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 681c235f-6dee-1401-e053-2991aa0addc0 | 2024-06-07 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 73920373-b45d-45d6-b183-d962467dde36 | 2024-05-24 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | fc426d0d-9774-4189-8d83-89aa85d926bb | 2024-05-22 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 712a6789-7aab-4114-ae92-d1c7686c6b96 | 2024-05-16 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 5b7666f3-4014-45ce-8387-3298d9fe6d25 | 2024-05-07 | Warnings, Adverse reactions | CEPHALEXIN |
| cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 141bd050-5dfc-68fa-e063-6394a90a6d86 | 2024-03-20 | Warnings, Adverse reactions | CEPHALEXIN |
| Cephalexin | CEPHALEXIN | ADVANCED RX PHARMACY OF TENNESSEE, LLC | af49507d-254f-296d-e053-2a95a90ad263 | 2024-03-12 | Warnings, Adverse reactions | CEPHALEXIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 48102-021 | Cephalexin | CEPHALEXIN | Fera Pharmaceuticals, LLC | NDA | Current |
| 48102-021 | Cephalexin | CEPHALEXIN | Fera Pharmaceuticals, LLC | NDA | Current |
| 48102-021 | Cephalexin | CEPHALEXIN | Fera Pharmaceuticals, LLC | NDA | Current |
| 58463-011 | KEFLEX | CEPHALEXIN | Pragma Pharmaceuticals, L | NDA | Current |
| 58463-011 | KEFLEX | CEPHALEXIN | Pragma Pharmaceuticals, LLC | NDA | Current |
| 58463-011 | KEFLEX | CEPHALEXIN | Pragma Pharmaceuticals, LLC | NDA | Current |
| 58463-012 | KEFLEX | CEPHALEXIN | Pragma Pharmaceuticals, L | NDA | Current |
| 58463-012 | KEFLEX | CEPHALEXIN | Pragma Pharmaceuticals, LLC | NDA | Current |
| 58463-012 | KEFLEX | CEPHALEXIN | Pragma Pharmaceuticals, LLC | NDA | Current |
| 58463-013 | KEFLEX | CEPHALEXIN | Pragma Pharmaceuticals, L | NDA | Current |
| 58463-013 | KEFLEX | CEPHALEXIN | Pragma Pharmaceuticals, LLC | NDA | Current |
| 58463-013 | KEFLEX | CEPHALEXIN | Pragma Pharmaceuticals, LLC | NDA | Current |
| 58463-013 | KEFLEX | CEPHALEXIN | Pragma Pharmaceuticals, LLC | NDA | Current |
| 59630-112 | Keflex | cephalexin | Shionogi Inc. | NDA | Current |
| 59630-113 | Keflex | cephalexin | Shionogi Inc. | NDA | Current |
| 59630-115 | Keflex | cephalexin | Shionogi Inc. | NDA | Current |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 73638 | SUPPL | 2023-03-01 |
| 56961 | SUPPL | 2018-12-21 |
| 56959 | SUPPL | 2018-12-21 |
| 56903 | SUPPL | 2018-12-20 |
| 56901 | SUPPL | 2018-12-20 |
| 38930 | SUPPL | 2015-11-04 |
| 7732 | SUPPL | 2015-11-04 |
| 30012 | SUPPL | 2008-09-17 |
| 30011 | SUPPL | 2008-05-21 |
| 17820 | SUPPL | 2006-05-16 |
| 7731 | SUPPL | 2006-05-16 |
| 7730 | SUPPL | 2004-12-02 |
| 30010 | SUPPL | 2004-07-01 |
| 38929 | SUPPL | 2004-01-22 |
| 30009 | SUPPL | 2004-01-22 |