Application 017956
- Type
- NDA
- Sponsor
- 3M
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | TEPANIL TEN-TAB | DIETHYLPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 75MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N017956-001 | TEPANIL TEN-TAB | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | 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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N017956-001 | TEPANIL TEN-TAB | 75MG | TABLET, EXTENDED RELEASE / ORAL | Approved before 1982 | e64feba35796… |
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 |
|---|---|---|---|---|---|---|
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | A-S Medication Solutions | 04f1a804-00f1-48f5-acfa-0ed1a8544784 | 2026-05-29 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| DIETHYLPROPION HYDROCHLORIDE | DIETHYLPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | ad0c3dc9-ae13-4853-bc8c-a66e2a69cc10 | 2025-10-15 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 0d213a24-ebbf-41df-8f32-de44a572829e | 2025-10-15 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| Diethylpropion Hydrochloride | DIETHYLPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5777eed8-c63d-49c4-9dd1-9d087906c368 | 2025-10-02 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | OMNIVIUM PHARMACEUTICALS LLC. | cd4f2b19-8752-4fed-81f3-d3074ade613c | 2025-09-19 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| DIETHYLPROPION HYDROCHLORIDE | DIETHYLPROPION HYDROCHLORIDE | Martek Pharmacal Co. | 130511dc-8f01-02ca-e063-6394a90a671b | 2025-07-21 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| DIETHYLPROPION HYDROCHLORIDE | DIETHYLPROPION HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 335fb85d-8b1f-e648-e063-6294a90aa158 | 2025-04-22 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 335265e0-1d5d-31fb-e063-6394a90a2e75 | 2025-04-21 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| DIETHYLPROPION HYDROCHLORIDE | DIETHYLPROPION HYDROCHLORIDE | Calvin Scott & Co., Inc. | fa48ad75-4fc8-4355-a19d-cd1b9d87f553 | 2025-02-27 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | Calvin Scott & Co., Inc. | d6cde8cc-26ae-4087-8eac-b11192749cc5 | 2025-02-25 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| DIETHYLPROPION HYDROCHLORIDE | DIETHYLPROPION HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | fe7e5022-8b58-aa4f-e053-6294a90af65e | 2025-02-04 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| Diethylpropion Hydrochloride | DIETHYLPROPION HYDROCHLORIDE | A-S Medication Solutions | 7f4eca5b-f850-44fc-88b4-4d9bcdf2ba44 | 2025-01-22 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| Diethylpropion Hydrochloride | DIETHYLPROPION HYDROCHLORIDE | Chartwell RX, LLC. | b8984c2d-244e-4c56-be3e-c402dc679b1f | 2024-10-10 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | Chartwell RX, LLC. | fdb6e69c-4f8e-42d8-bdda-c99ff3ad7c1e | 2024-10-10 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| Diethylpropion Hydrochloride | DIETHYLPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 54655904-7ce2-49d5-9acf-81ad9680d215 | 2024-10-02 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| DIETHYLPROPION HYDROCHLORIDE | DIETHYLPROPION HYDROCHLORIDE | Bryant Ranch Prepack | fb8e2f1b-24ef-4e1d-a493-4c3b3de05b26 | 2024-08-07 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 89306917-a65b-40d4-9c51-d59ac0ad2017 | 2024-08-07 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| DIETHYLPROPION HYDROCHLORIDE | DIETHYLPROPION HYDROCHLORIDE | KVK-TECH, INC | 3ecb7bd7-e04c-47fe-859a-8ba8a54f9aff | 2024-05-01 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | Lannett Company, Inc. | dab53f4f-68d4-4477-a2b6-ad44a956332b | 2022-07-27 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |
| Diethylpropion Hydrochloride | DIETHYLPROPION HYDROCHLORIDE | Proficient Rx LP | 2a2fbc1b-6430-485b-b581-10fbfca0af88 | 2020-10-01 | Warnings, Adverse reactions | DIETHYLPROPION HYDROCHLORIDE |