Application 205019
- Type
- ANDA
- Sponsor
- NUVO PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | CAPSULE;ORAL | 15MG | No | No |
| 002 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A205019-001 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | |
| A205019-002 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A205019-001 | AA |
| A205019-002 | AA |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205019-001 | PHENTERMINE HYDROCHLORIDE | 15MG | CAPSULE / ORAL | AA | 2014-12-05 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A205019-002 | PHENTERMINE HYDROCHLORIDE | 30MG | CAPSULE / ORAL | AA | 2014-12-05 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2022-03-09 01:35 UTC | 2022-03 | A205019-001 | AA | 1 | bb7c543d1eb4… |
| 2022-03-09 01:35 UTC | 2022-03 | A205019-002 | AA | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A205019-001 | AA | 1 | 782e0a99824c… |
| 2021-12-28 21:50 UTC | 2021-12 | A205019-002 | AA | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205019-001 | AA | 1 | 87673890dc5c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A205019-002 | AA | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A205019-001 | AA | 1 | 5aa47cf7b7d7… |
| 2021-03-12 10:30 UTC | 2021-03 | A205019-002 | AA | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A205019-001 | AA | 1 | 8869cabd3fbd… |
| 2020-12-22 03:56 UTC | 2020-12 | A205019-002 | AA | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A205019-001 | AA | 1 | c0c555d07b60… |
| 2020-11-12 02:37 UTC | 2020-11 | A205019-002 | AA | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A205019-001 | AA | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A205019-002 | AA | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A205019-001 | AA | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A205019-002 | AA | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A205019-001 | AA | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A205019-002 | AA | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205019-001 | AA | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A205019-002 | AA | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A205019-001 | AA | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | A205019-002 | AA | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A205019-001 | AA | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | A205019-002 | AA | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205019-001 | AA | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A205019-002 | AA | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205019-001 | AA | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A205019-002 | AA | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205019-001 | AA | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A205019-002 | AA | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205019-001 | AA | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A205019-002 | AA | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A205019-001 | AA | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | A205019-002 | AA | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A205019-001 | AA | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | A205019-002 | AA | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205019-001 | AA | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A205019-002 | AA | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | A205019-001 | AA | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | A205019-002 | AA | 1 | f41ea6bd6efb… |
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 |
|---|---|---|---|---|---|---|
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 70bc6f36-8087-4ccd-a396-a911c0ebae79 | 2026-08-17 | Warnings, Adverse reactions | 205019 ANDA205019 68788-7740 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | d77f31b4-7e36-4a0a-a55b-78b4b6ab5cb7 | 2026-08-17 | Warnings, Adverse reactions | 205019 ANDA205019 68788-7972 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 130e6087-0ab6-4456-a781-d370f363dc38 | 2026-06-01 | Warnings, Adverse reactions | 205019 ANDA205019 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Calvin Scott & Co., Inc. | d24aaa53-9c78-4c1b-9495-c785a9cf2b26 | 2026-05-21 | Warnings, Adverse reactions | 205019 ANDA205019 17224-851 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | A-S Medication Solutions | c53bd3c5-01f6-4a21-9e3c-aa4969a01b4b | 2026-03-04 | Warnings, Adverse reactions | 205019 ANDA205019 50090-5998 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | fa5de92d-a5bf-4ae1-8e13-ad827aeebea3 | 2026-02-04 | Warnings, Adverse reactions | 205019 ANDA205019 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | a9270c14-499f-4c07-a1eb-c0aab5d8731f | 2025-10-29 | Warnings, Adverse reactions | 205019 ANDA205019 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 640d71d8-45c9-42fb-ad96-2f3ac60afc9c | 2025-09-05 | Warnings, Adverse reactions | 205019 ANDA205019 63629-8528 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | fe78b5b4-47bf-484b-ab37-e0d7de6fad57 | 2025-09-05 | Warnings, Adverse reactions | 205019 ANDA205019 63629-8537 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | e4508aa9-1e7a-4af7-829e-5fa353c92f5e | 2025-08-22 | Warnings, Adverse reactions | 205019 ANDA205019 72789-287 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | SUNRISE PHARMACEUTICAL, INC. | a0439c85-5ede-4e02-aed2-47debd2c8eb2 | 2025-07-08 | Warnings, Adverse reactions | 205019 ANDA205019 11534-157 11534-176 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | a1bca4b5-df64-4bac-a3a2-67f5c1eddbce | 2025-05-12 | Warnings, Adverse reactions | 205019 ANDA205019 |
| Phentermine HCL C-IV | PHENTERMINE HCL C-IV | Direct_Rx | e4a2996e-2bfa-376f-e053-2995a90a0ed1 | 2025-01-22 | Warnings, Adverse reactions | 205019 ANDA205019 72189-365 |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | DirectRx | ca683656-16a6-9602-e053-2a95a90aa895 | 2025-01-20 | Warnings, Adverse reactions | 205019 ANDA205019 72189-253 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | c8516abe-5ad1-4b76-8e2c-96ee455979cf | 2024-10-17 | Warnings, Adverse reactions | 205019 ANDA205019 63629-2385 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | f427f067-f1a7-4d60-8ce0-90b20e2d4eb5 | 2024-08-20 | Warnings, Adverse reactions | 205019 ANDA205019 63629-2384 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | f50f5453-e06d-4e39-b868-9bdadf1d8baa | 2024-08-20 | Warnings, Adverse reactions | 205019 ANDA205019 63629-2383 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 3c37d637-779d-4097-85ef-e4ce7d0fb86a | 2024-08-08 | Warnings, Adverse reactions | 205019 ANDA205019 71335-1860 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 81751ece-8ccb-4aec-91ad-037c1d9fea53 | 2023-11-16 | Warnings, Adverse reactions | 205019 ANDA205019 71335-1933 |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Asclemed USA, Inc. | 22683183-a828-47a4-9e52-38175d7c6f21 | 2023-09-01 | Warnings, Adverse reactions | 205019 ANDA205019 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 11534-157 | Phentermine Hydrochloride | phentermine hydrochloride | SUNRISE PHARMACEUTICAL, INC. | ANDA | Current |
| 11534-157 | Phentermine Hydrochloride | phentermine hydrochloride | SUNRISE PHARMACEUTICAL, INC. | ANDA | Current |
| 11534-157 | Phentermine Hydrochloride | phentermine hydrochloride | SUNRISE PHARMACEUTICAL, INC. | ANDA | Current |
| 11534-176 | Phentermine Hydrochloride | phentermine hydrochloride | SUNRISE PHARMACEUTICAL, INC. | ANDA | Current |
| 11534-176 | Phentermine Hydrochloride | phentermine hydrochloride | SUNRISE PHARMACEUTICAL, INC. | ANDA | Current |
| 11534-176 | Phentermine Hydrochloride | phentermine hydrochloride | SUNRISE PHARMACEUTICAL, INC. | ANDA | Current |
| 17224-851 | Phentermine Hydrochloride | phentermine hydrochloride | CALVIN, SCOTT AND COMPANY, INCORPORATED | ANDA | Current |
| 50090-5998 | Phentermine Hydrochloride | phentermine hydrochloride | A-S Medication Solutions | ANDA | Current |
| 63629-2383 | Phentermine Hydrochloride | phentermine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2383 | Phentermine Hydrochloride | phentermine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2384 | Phentermine Hydrochloride | phentermine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2384 | Phentermine Hydrochloride | phentermine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2385 | Phentermine Hydrochloride | phentermine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-2385 | Phentermine Hydrochloride | phentermine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8528 | Phentermine Hydrochloride | phentermine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8528 | Phentermine Hydrochloride | phentermine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 63629-8537 | Phentermine Hydrochloride | phentermine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 68071-2640 | Phentermine Hydrochloride | phentermine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2640 | Phentermine Hydrochloride | phentermine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2640 | Phentermine Hydrochloride | phentermine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2888 | Phentermine Hydrochloride | phentermine hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68788-7740 | Phentermine Hydrochloride | phentermine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7740 | Phentermine Hydrochloride | phentermine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7740 | Phentermine Hydrochloride | phentermine hydrochloride | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7972 | Phentermine Hydrochloride | phentermine hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7972 | Phentermine Hydrochloride | phentermine hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7972 | Phentermine Hydrochloride | phentermine hydrochloride | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 71205-564 | Phentermine Hydrochloride | phentermine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71205-564 | Phentermine Hydrochloride | phentermine hydrochloride | Proficient Rx LP | ANDA | Current |
| 71335-1860 | Phentermine Hydrochloride | phentermine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1933 | Phentermine Hydrochloride | phentermine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 71335-1933 | Phentermine Hydrochloride | phentermine hydrochloride | Bryant Ranch Prepack | ANDA | Current |
| 72189-253 | PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | DirectRx | ANDA | Current |
| 72189-365 | Phentermine HCL C-IV | Phentermine HCL C-IV | Direct_Rx | ANDA | Current |
| 72789-287 | Phentermine Hydrochloride | phentermine hydrochloride | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |