Application 091680
- Type
- ANDA
- Sponsor
- LANNETT CO INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DIETHYLPROPION HYDROCHLORIDE | DIETHYLPROPION HYDROCHLORIDE | TABLET, EXTENDED RELEASE;ORAL | 75MG | No | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091680-001 | DIETHYLPROPION HYDROCHLORIDE | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 |
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 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | 2011-10-24 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | RS | 2011-10-24 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A091680-001 | DIETHYLPROPION HYDROCHLORIDE | 75MG | TABLET, EXTENDED RELEASE / ORAL | AB | RS | 2011-10-24 | 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 | A091680-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A091680-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A091680-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A091680-001 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A091680-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A091680-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A091680-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A091680-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A091680-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A091680-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A091680-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A091680-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A091680-001 | AB | 1 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | A091680-001 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A091680-001 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A091680-001 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A091680-001 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A091680-001 | AB | 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 |
|---|---|---|---|---|---|---|
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | A-S Medication Solutions | 04f1a804-00f1-48f5-acfa-0ed1a8544784 | 2026-05-29 | Warnings, Adverse reactions | 091680 ANDA091680 50090-0120 |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 0d213a24-ebbf-41df-8f32-de44a572829e | 2025-10-15 | Warnings, Adverse reactions | 091680 ANDA091680 43063-532 |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | OMNIVIUM PHARMACEUTICALS LLC. | cd4f2b19-8752-4fed-81f3-d3074ade613c | 2025-09-19 | Warnings, Adverse reactions | 091680 ANDA091680 |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | NuCare Pharmaceuticals, Inc. | 335265e0-1d5d-31fb-e063-6394a90a2e75 | 2025-04-21 | Warnings, Adverse reactions | 091680 ANDA091680 |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | Calvin Scott & Co., Inc. | d6cde8cc-26ae-4087-8eac-b11192749cc5 | 2025-02-25 | Warnings, Adverse reactions | 091680 ANDA091680 |
| DIETHYLPROPION HYDROCHLORIDE ER | DIETHYLPROPION HYDROCHLORIDE ER | Directrx | d44e23db-381a-cfc3-e053-2995a90a13c8 | 2025-01-21 | Warnings, Adverse reactions | 091680 ANDA091680 72189-307 |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | Chartwell RX, LLC. | fdb6e69c-4f8e-42d8-bdda-c99ff3ad7c1e | 2024-10-10 | Warnings, Adverse reactions | 091680 ANDA091680 |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | Bryant Ranch Prepack | 89306917-a65b-40d4-9c51-d59ac0ad2017 | 2024-08-07 | Warnings, Adverse reactions | 091680 ANDA091680 71335-0049 |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | Lannett Company, Inc. | dab53f4f-68d4-4477-a2b6-ad44a956332b | 2022-07-27 | Warnings, Adverse reactions | 091680 ANDA091680 0527-1477 |
| Diethylpropion Hydrochloride ER | DIETHYLPROPION HYDROCHLORIDE | Proficient Rx LP | 15110f70-6602-4e05-a4b5-716a86dcaed5 | 2019-11-01 | Warnings, Adverse reactions | 091680 ANDA091680 63187-621 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-1477 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1477 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1477 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1477 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 17224-360 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | CALVIN, SCOTT AND COMPANY, INCORPORATED | ANDA | Current |
| 17224-360 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | CALVIN, SCOTT AND COMPANY, INCORPORATED | ANDA | Current |
| 33261-354 | Diethylpropion HydrochlorideER | Diethylpropion Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 43063-532 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-532 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-532 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-532 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-532 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-532 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 50090-0120 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0120 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0120 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0120 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0120 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 52959-329 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 63187-621 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | Proficient Rx LP | ANDA | Current |
| 63187-621 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | Proficient Rx LP | ANDA | Current |
| 68788-9423 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9423 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-9423 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 71335-0049 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0049 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0049 | Diethylpropion Hydrochloride | Diethylpropion Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72189-307 | DIETHYLPROPION HYDROCHLORIDE ER | DIETHYLPROPION HYDROCHLORIDE ER | Directrx | ANDA | Current |