Application 065326
- Type
- ANDA
- Sponsor
- ORCHID HLTHCARE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CEPHALEXIN | CEPHALEXIN | FOR SUSPENSION;ORAL | EQ 125MG BASE/5ML | No | No |
| 002 | CEPHALEXIN | CEPHALEXIN | FOR SUSPENSION;ORAL | EQ 250MG BASE/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A065326-001 | CEPHALEXIN | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | ||
| A065326-002 | CEPHALEXIN | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 |
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 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | 2006-07-10 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2006-07-10 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2006-07-10 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065326-001 | CEPHALEXIN | EQ 125MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2006-07-10 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A065326-002 | CEPHALEXIN | EQ 250MG BASE/5ML | FOR SUSPENSION / ORAL | AB | 2006-07-10 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-04-04 05:41 UTC | 2022-04 | A065326-001 | AB | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A065326-002 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A065326-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A065326-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A065326-001 | AB | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A065326-002 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A065326-001 | AB | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A065326-002 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065326-001 | AB | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A065326-002 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A065326-001 | AB | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A065326-002 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A065326-001 | AB | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A065326-002 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A065326-001 | AB | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A065326-002 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A065326-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A065326-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A065326-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A065326-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A065326-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A065326-002 | 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 | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 6e5f9616-ddf2-19c4-e053-2991aa0a372a | 2024-07-18 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | ada33464-b416-9ac6-e053-2a95a90af787 | 2024-07-17 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | ade02343-3e4b-b1f1-e053-2995a90ac5fe | 2024-07-17 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | a33280d4-7caf-f74b-e053-2a95a90a90c3 | 2024-07-17 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc | 945552cb-90e4-41fb-afe2-8ee8785e94da | 2024-07-17 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 3fcb3f88-9dfc-444d-952a-1d1967720525 | 2024-06-28 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc. | 4eb58a7e-1c92-4be3-b702-e522e0fbf425 | 2024-06-21 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | Asclemed USA, Inc. | 20f8cc57-231c-4d36-a209-ff9e5735d65c | 2024-06-20 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 90a76d24-e5a9-9000-e053-2a95a90ae8af | 2024-06-19 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 6ac71dc8-7f86-60c5-e053-2a91aa0a2a7e | 2024-06-10 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 6be20569-df34-04d9-e053-2991aa0a94fd | 2024-06-10 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 728c5212-dbd8-8df5-e053-2a91aa0a9579 | 2024-06-10 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 681c235f-6dee-1401-e053-2991aa0addc0 | 2024-06-07 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 73920373-b45d-45d6-b183-d962467dde36 | 2024-05-24 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | fc426d0d-9774-4189-8d83-89aa85d926bb | 2024-05-22 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 712a6789-7aab-4114-ae92-d1c7686c6b96 | 2024-05-16 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | A-S Medication Solutions | 5b7666f3-4014-45ce-8387-3298d9fe6d25 | 2024-05-07 | Warnings, Adverse reactions | Cephalexin CEPHALEXIN |
| cephalexin | CEPHALEXIN | NuCare Pharmaceuticals,Inc. | 141bd050-5dfc-68fa-e063-6394a90a6d86 | 2024-03-20 | Warnings, Adverse reactions | cephalexin CEPHALEXIN |
| Cephalexin | CEPHALEXIN | ADVANCED RX PHARMACY OF TENNESSEE, LLC | af49507d-254f-296d-e053-2a95a90ad263 | 2024-03-12 | Warnings, Adverse reactions | Cephalexin 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 |
|---|---|---|---|---|---|
| 42043-142 | Cephalexin | Cephalexin | OrchidPharma Inc | ANDA | Current |
| 42043-142 | Cephalexin | Cephalexin | OrchidPharma Inc | ANDA | Current |
| 42043-143 | Cephalexin | Cephalexin | OrchidPharma Inc | ANDA | Current |
| 42043-143 | Cephalexin | Cephalexin | OrchidPharma Inc | ANDA | Current |
| 42254-338 | Cephalexin | Cephalexin | Rebel Distributors Corp | ANDA | Current |
| 50090-2552 | Cephalexin | Cephalexin | A-S Medication Solutions | ANDA | Current |
| 55700-563 | Cephalexin | Cephalexin | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 59834-202 | Cephalexin | Cephalexin | OrchidPharma Inc | ANDA | Current |
| 59834-203 | Cephalexin | Cephalexin | OrchidPharma Inc | ANDA | Current |
| 66267-981 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 66267-981 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1585 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-1585 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4233 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4233 | Cephalexin | Cephalexin | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7391 | Cephalexin | Cephalexin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7391 | Cephalexin | Cephalexin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8986 | Cephalexin | Cephalexin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8986 | Cephalexin | Cephalexin | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8986 | Cephalexin | Cephalexin | Preferred Pharmaceuticals Inc. | ANDA | Current |