Application 080712
- Type
- ANDA
- Sponsor
- BEL MAR
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | INJECTABLE;INJECTION | 200MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A080712-001 | THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A080712-001 | THIAMINE HYDROCHLORIDE | 200MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 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 |
|---|---|---|---|---|---|---|
| thiamine hydrochloride | THIAMINE HYDROCHLORIDE | Sagent Pharmaceuticals | 5982cf83-01d6-4acb-8373-339079b8a76e | 2026-07-22 | Warnings, Adverse reactions | thiamine hydrochloride THIAMINE HYDROCHLORIDE |
| Thiamine | THIAMINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | c3c9db74-95d4-487c-90c3-c810786fbaec | 2026-01-14 | Warnings, Adverse reactions | THIAMINE HYDROCHLORIDE |
| Thiamine | THIAMINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | ca4899c6-cea1-48d6-b0ae-9efcf67f6fcb | 2026-01-13 | Warnings, Adverse reactions | THIAMINE HYDROCHLORIDE |
| Thiamine | THIAMINE HYDROCHLORIDE | Fresenius Kabi USA, LLC | af3f9344-f743-4bad-b319-53b96e13fee2 | 2026-01-09 | Warnings, Adverse reactions | THIAMINE HYDROCHLORIDE |
| Thiamine Hydrochloride | THIAMINE HYDROCHLORIDE | ONESOURCE SPECIALTY PHARMA LIMITED | 2e957a35-83b3-47f5-ad09-216b22cc30be | 2025-11-20 | Warnings, Adverse reactions | Thiamine Hydrochloride THIAMINE HYDROCHLORIDE |
| THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | Henry Schein, Inc. | 3bdf3b03-90cf-4416-9344-7733b193adf5 | 2025-11-07 | Warnings, Adverse reactions | THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE |
| Thiamine Hydrochloride | THIAMINE HYDROCHLORIDE | Eugia US LLC | 4985bf3c-abe5-4bbb-9dcc-6de387d36d6b | 2025-10-23 | Warnings, Adverse reactions | Thiamine Hydrochloride THIAMINE HYDROCHLORIDE |
| Thiamine Hydrochloride | THIAMINE HYDROCHLORIDE | REMEDYREPACK INC. | 0f38c4ba-cebf-49f4-b0a6-8a5d3ebf618c | 2025-09-30 | Warnings, Adverse reactions | Thiamine Hydrochloride THIAMINE HYDROCHLORIDE |
| THIAMINE HYDROCHLORIDE | THIAMINE HYDROCHLORIDE | Henry Schein, Inc. | c006eca3-137a-493f-bbc4-f04e463d66f9 | 2025-09-26 | Warnings, Adverse reactions | THIAMINE HYDROCHLORIDE THIAMINE HYDROCHLORIDE |
| Thiamine Hydrochloride | THIAMINE HYDROCHLORIDE | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 764d608a-d821-4447-85e1-6af297abb4c1 | 2025-07-16 | Warnings, Adverse reactions | Thiamine Hydrochloride THIAMINE HYDROCHLORIDE |
| Thiamine Hydrochloride | THIAMINE HYDROCHLORIDE | Fosun Pharma USA Inc. | 3649f7b5-dcce-b246-e063-6394a90a3145 | 2025-06-19 | Warnings, Adverse reactions | Thiamine Hydrochloride THIAMINE HYDROCHLORIDE |
| thiamine hydrochloride | THIAMINE HYDROCHLORIDE | Gland Pharma Limited | fc0265cd-d13a-477c-8c2c-8d44fd86444e | 2025-02-27 | Warnings, Adverse reactions | thiamine hydrochloride THIAMINE HYDROCHLORIDE |
| Thiamine Hydrochloride | THIAMINE HYDROCHLORIDE | Camber Pharmaceuticals, Inc. | 2d402a31-3240-42a0-bd34-8fccd6a792d3 | 2025-02-03 | Warnings, Adverse reactions | Thiamine Hydrochloride THIAMINE HYDROCHLORIDE |
| Thiamine | THIAMINE HYDROCHLORIDE | Caplin Steriles Limited | 8909424c-9d5b-4e35-b2d3-da9d3316a4cc | 2024-05-20 | Warnings, Adverse reactions | THIAMINE HYDROCHLORIDE |
| Thiamine Hydrochloride | THIAMINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 63f3631b-ba1e-430c-a30b-dd05b2c00c13 | 2024-04-11 | Warnings, Adverse reactions | Thiamine Hydrochloride THIAMINE HYDROCHLORIDE |
| Thiamine | THIAMINE HYDROCHLORIDE | Armas Pharmaceuticals Inc. | 9ecbf165-bd2e-4bc1-a52c-1f40d1c2bbd9 | 2023-05-22 | Warnings, Adverse reactions | THIAMINE HYDROCHLORIDE |
| Thiamine | THIAMINE HYDROCHLORIDE | NorthStar Rx LLC | f4790075-a740-4550-9d4c-69a00dac354c | 2023-04-20 | Warnings, Adverse reactions | THIAMINE HYDROCHLORIDE |
| Thiamine Hydrochloride | THIAMINE HYDROCHLORIDE | Dr. Reddy's Laboratories Inc. | 43926cec-e483-8cf1-4d8d-5145e554d45d | 2022-12-30 | Warnings, Adverse reactions | Thiamine Hydrochloride THIAMINE HYDROCHLORIDE |
| Thiamine Hydrochloride | THIAMINE HYDROCHLORIDE | Mylan Institutional LLC | 12986d0e-b8bf-4338-9d85-07f973b35439 | 2021-04-15 | Warnings, Adverse reactions | Thiamine Hydrochloride THIAMINE HYDROCHLORIDE |