Application 077399
- Type
- ANDA
- Sponsor
- HI TECH PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LEVOCARNITINE | LEVOCARNITINE | SOLUTION;ORAL | 1GM/10ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077399-001 | LEVOCARNITINE | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | 2007-10-25 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | A077399-001 | LEVOCARNITINE | 1GM/10ML | SOLUTION / ORAL | AA | 2007-10-25 | e64feba35796… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077399-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A077399-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A077399-001 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A077399-001 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A077399-001 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A077399-001 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A077399-001 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A077399-001 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A077399-001 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A077399-001 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A077399-001 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077399-001 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077399-001 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A077399-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A077399-001 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A077399-001 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A077399-001 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A077399-001 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A077399-001 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A077399-001 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A077399-001 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A077399-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A077399-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A077399-001 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A077399-001 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A077399-001 | AA | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| LEVOCARNITINE | LEVOCARNITINE | Baxter Healthcare Corporation | 1f38ab0d-ef89-4e92-990f-9da190057e17 | 2026-07-02 | Warnings, Adverse reactions | LEVOCARNITINE LEVOCARNITINE |
| Levocarnitine | LEVOCARNITINE | ANI Pharmaceuticals, Inc. | 18dc8eae-56c1-46ec-9d21-e17d7b2f91db | 2025-12-30 | Warnings, Adverse reactions | Levocarnitine LEVOCARNITINE |
| Levocarnitine | LEVOCARNITINE | ANI Pharmaceuticals, Inc. | bfd0d39f-d3b2-4f0d-b7a2-071a545900f4 | 2025-12-30 | Warnings, Adverse reactions | Levocarnitine LEVOCARNITINE |
| levocarnitine | LEVOCARNITINE | Devatis Inc. | 79b6182c-ead5-4fdd-bafa-1afbc7a77906 | 2025-09-16 | Warnings, Adverse reactions | levocarnitine LEVOCARNITINE |
| Levocarnitine | LEVOCARNITINE | Rising Pharma Holdings, Inc. | ada35959-e317-4161-ae79-3475096c679f | 2025-07-17 | Warnings, Adverse reactions | Levocarnitine LEVOCARNITINE |
| Levocarnitine | LEVOCARNITINE ORAL | Saptalis Pharmaceuticals, LLC | 75b43fb1-4486-48a0-b571-7754dce350a3 | 2025-03-18 | Warnings, Adverse reactions | Levocarnitine |
| Levocarnitine | LEVOCARNITINE | TRUPHARMA, LLC | 05ab18c1-fb01-48fa-8f05-0200bb8a5edf | 2024-12-27 | Warnings, Adverse reactions | Levocarnitine LEVOCARNITINE |
| Carnitor SF | LEVOCARNITINE | Leadiant Biosciences, Inc. | dd904490-83f3-4cd3-bb6f-68e28509b4b6 | 2024-11-04 | Warnings, Adverse reactions | LEVOCARNITINE |
| CARNITOR | LEVOCARNITINE | Leadiant Biosciences, Inc. | d2133bc3-9c15-48bd-8b16-b8995a6a14cd | 2024-10-30 | Warnings, Adverse reactions | LEVOCARNITINE |
| Levocarnitine | LEVOCARNITINE | Rising Pharma Holdings, Inc. | 0f749812-8f02-4eeb-91d9-5dd6fc9fa159 | 2024-08-19 | Warnings, Adverse reactions | Levocarnitine LEVOCARNITINE |
| Carnitor | LEVOCARNITINE | Leadiant Biosciences, Inc. | b2cbc620-59fd-47b6-9e4b-7e3e31533a1c | 2024-01-23 | Warnings, Adverse reactions | LEVOCARNITINE |
| Carnitor | LEVOCARNITINE | Leadiant Biosciences, Inc. | cf801cc4-775e-433d-9d32-e5d9a98981d3 | 2023-11-20 | Warnings, Adverse reactions | LEVOCARNITINE |
| Levocarnitine | LEVOCARNITINE | American Regent, Inc. | cc4da2c3-f939-444d-9b5b-a57b6051c190 | 2023-06-23 | Warnings, Adverse reactions | Levocarnitine LEVOCARNITINE |
| Levocarnitine | LEVOCARNITINE | Hikma Pharmaceuticals USA Inc. | 8f255df8-8a1f-4b4f-ae8c-2c80532ce8d4 | 2023-01-06 | Warnings, Adverse reactions | Levocarnitine LEVOCARNITINE |