Application 087022
- Type
- ANDA
- Sponsor
- LANNETT
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | No | No |
| 002 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | CAPSULE;ORAL | 15MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A087022-001 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | ||
| A087022-002 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 |
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 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | 1983-02-03 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | 2012-01-20 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 1983-02-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2012-01-20 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 1983-02-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2012-01-20 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 1983-02-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2012-01-20 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 1983-02-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2012-01-20 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 1983-02-03 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2012-01-20 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | A087022-001 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 1983-02-03 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A087022-002 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2012-01-20 | 782e0a99824c… |
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 | A087022-001 | AA | 1 | 5c6f7cd8ea54… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A087022-002 | AA | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A087022-001 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-08 23:34 UTC | 2022-04 | A087022-002 | AA | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A087022-001 | AA | 1 | 4b0b4de00fa7… |
| 2022-04-04 05:41 UTC | 2022-04 | A087022-002 | AA | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A087022-001 | AA | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A087022-002 | AA | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A087022-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A087022-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A087022-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A087022-002 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A087022-001 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A087022-002 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A087022-001 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A087022-002 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A087022-001 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A087022-002 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A087022-001 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A087022-002 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A087022-001 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A087022-002 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A087022-001 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A087022-002 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A087022-001 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A087022-002 | AA | 1 | ea99ee380514… |
| 2023-01-26 05:58 UTC | 2023-01 | A087022-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A087022-002 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A087022-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A087022-002 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A087022-001 | AA | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A087022-002 | AA | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | A087022-001 | AA | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | A087022-002 | AA | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A087022-001 | AA | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | A087022-002 | 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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0527-0597 | Phentermine Hydrochloride | Phentermine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-0597 | Phentermine Hydrochloride | Phentermine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-0597 | Phentermine Hydrochloride | Phentermine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1308 | Phentermine Hydrochloride | Phentermine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1308 | Phentermine Hydrochloride | Phentermine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1308 | Phentermine Hydrochloride | Phentermine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1310 | Phentermine Hydrochloride | Phentermine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1310 | Phentermine Hydrochloride | Phentermine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1310 | Phentermine Hydrochloride | Phentermine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1742 | Phentermine Hydrochloride | Phentermine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1742 | Phentermine Hydrochloride | Phentermine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 0527-1742 | Phentermine Hydrochloride | Phentermine Hydrochloride | Lannett Company, Inc. | ANDA | Current |
| 10544-098 | Phentermine Hydrochloride | Phentermine Hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 10544-593 | Phentermine Hydrochloride | Phentermine Hydrochloride | Blenheim Pharmacal, Inc. | ANDA | Current |
| 21695-510 | Phentermine Hydrochloride | Phentermine Hydrochloride | Rebel Distributors Corp | ANDA | Current |
| 50090-0415 | Phentermine Hydrochloride | Phentermine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0415 | Phentermine Hydrochloride | Phentermine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-0415 | Phentermine Hydrochloride | Phentermine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3535 | Phentermine Hydrochloride | Phentermine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50090-3535 | Phentermine Hydrochloride | Phentermine Hydrochloride | A-S Medication Solutions | ANDA | Current |
| 50436-1310 | Phentermine Hydrochloride | Phentermine Hydrochloride | Unit Dose Services | ANDA | Current |
| 50436-3176 | Phentermine Hydrochloride | Phentermine Hydrochloride | Unit Dose Services | ANDA | Current |
| 52959-432 | Phentermine Hydrochloride | Phentermine Hydrochloride | H.J. Harkins Company, Inc. | ANDA | Current |
| 53217-330 | Phentermine Hydrochloride | Phentermine Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 53217-334 | Phentermine Hydrochloride | Phentermine Hydrochloride | Aidarex Pharmaceuticals LLC | ANDA | Current |
| 61919-557 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | Direct_Rx | ANDA | Current |
| 63629-2949 | Phentermine Hydrochloride | Phentermine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 68071-3241 | Phentermine Hydrochloride | Phentermine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3241 | Phentermine Hydrochloride | Phentermine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68071-3241 | Phentermine Hydrochloride | Phentermine Hydrochloride | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7836 | Phentermine Hydrochloride | Phentermine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8942 | Phentermine Hydrochloride | Phentermine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8942 | Phentermine Hydrochloride | Phentermine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8942 | Phentermine Hydrochloride | Phentermine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8950 | Phentermine Hydrochloride | Phentermine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8950 | Phentermine Hydrochloride | Phentermine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8950 | Phentermine Hydrochloride | Phentermine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8950 | Phentermine Hydrochloride | Phentermine Hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71205-340 | Phentermine Hydrochloride | Phentermine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-340 | Phentermine Hydrochloride | Phentermine Hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-0474 | Phentermine Hydrochloride | Phentermine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0474 | Phentermine Hydrochloride | Phentermine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0474 | Phentermine Hydrochloride | Phentermine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-0474 | Phentermine Hydrochloride | Phentermine Hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72189-071 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | direct rx | ANDA | Current |
| 72189-071 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | direct rx | ANDA | Current |