Application 202088
- Type
- NDA
- Sponsor
- CITIUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUPRENZA | PHENTERMINE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 002 | SUPRENZA | PHENTERMINE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
| 003 | SUPRENZA | PHENTERMINE HYDROCHLORIDE | TABLET, ORALLY DISINTEGRATING;ORAL | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N202088-001 | SUPRENZA | PHENTERMINE HYDROCHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | ||
| N202088-002 | SUPRENZA | PHENTERMINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | ||
| N202088-003 | SUPRENZA | PHENTERMINE HYDROCHLORIDE | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | |
| N202088-002 | 8440170 | 2029-03-14 | Drug product | ||
| N202088-003 | 8440170 | 2029-03-14 | Drug product |
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 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202088-002 | SUPRENZA | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202088-003 | SUPRENZA | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202088-001 | SUPRENZA | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | 301d65b070ca… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N202088-002 | 8440170 | 2029-03-14 | Drug product | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N202088-003 | 8440170 | 2029-03-14 | Drug product | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N202088-002 | 8440170 | 2029-03-14 | Drug product | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N202088-003 | 8440170 | 2029-03-14 | Drug product | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N202088-002 | 8440170 | 2029-03-14 | Drug product | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N202088-003 | 8440170 | 2029-03-14 | Drug product | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202088-002 | 8440170 | 2029-03-14 | Drug product | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N202088-003 | 8440170 | 2029-03-14 | Drug product | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N202088-002 | 8440170 | 2029-03-14 | Drug product | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N202088-003 | 8440170 | 2029-03-14 | Drug product | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202088-002 | 8440170 | 2029-03-14 | Drug product | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N202088-003 | 8440170 | 2029-03-14 | Drug product | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202088-002 | 8440170 | 2029-03-14 | Drug product | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N202088-003 | 8440170 | 2029-03-14 | Drug product | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202088-002 | 8440170 | 2029-03-14 | Drug product | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N202088-003 | 8440170 | 2029-03-14 | Drug product | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202088-002 | 8440170 | 2029-03-14 | Drug product | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N202088-003 | 8440170 | 2029-03-14 | Drug product | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202088-002 | 8440170 | 2029-03-14 | Drug product | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N202088-003 | 8440170 | 2029-03-14 | Drug product | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202088-002 | 8440170 | 2029-03-14 | Drug product | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N202088-003 | 8440170 | 2029-03-14 | Drug product | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N202088-002 | 8440170 | 2029-03-14 | Drug product | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N202088-003 | 8440170 | 2029-03-14 | Drug product | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202088-002 | 8440170 | 2029-03-14 | Drug product | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N202088-003 | 8440170 | 2029-03-14 | Drug product | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N202088-001 | 8440170 | 2029-03-14 | Drug product | 2013-06-03 | 301d65b070ca… |
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 | Bryant Ranch Prepack | 53cad049-f1b4-42c0-9cc7-a1c2df75ac58 | 2024-08-20 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | bd7393cb-2b72-4ecd-ba03-801b635b7647 | 2024-08-08 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 3c37d637-779d-4097-85ef-e4ce7d0fb86a | 2024-08-08 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 0ca26b58-0a93-4a10-be4d-63a4ad5eecf8 | 2024-06-06 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 7f1c3a5d-dd9b-4441-a483-aa5777f8e40c | 2024-05-29 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | KVK-Tech, Inc. | b963f7bb-fa65-4e28-81c9-282fbe70a6a6 | 2024-04-18 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | ac8559a0-98fe-4737-b9ec-e36eef3b14fc | 2024-04-08 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | c5d60a6d-2410-4a3c-88e1-a6126b56cf6a | 2024-04-08 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | KVK-TECH, Inc. | 3b44d104-a7d0-4366-9d42-63f784f3cb22 | 2024-02-14 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 95f908c2-1003-4e8f-8e4a-86f493456878 | 2024-01-15 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| LOMAIRA | PHENTERMINE HYDROCHLORIDE | KVK-TECH, INC. | cde9fb09-e5af-434d-8874-e4f9f974d893 | 2023-12-19 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 81751ece-8ccb-4aec-91ad-037c1d9fea53 | 2023-11-16 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 707af68e-1630-4f86-87ba-1a643d2b4ef9 | 2023-10-09 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 83802088-f4fc-4b34-9268-d63fb2ad1655 | 2023-09-27 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Asclemed USA, Inc. | 22683183-a828-47a4-9e52-38175d7c6f21 | 2023-09-01 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Proficient Rx LP | b14a8f6a-a1c6-4104-80f2-0fa35320d04c | 2023-05-01 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Calvin Scott & Co., Inc. | f938b0ab-606e-8b21-e053-6294a90a4f4c | 2023-04-13 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Proficient Rx LP | 5e1cc734-5d5c-429e-8b4c-4401a01cfba2 | 2023-04-01 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | A-S Medication Solutions | 8c7c1391-bfd1-48f9-b249-9729fe648b89 | 2023-02-04 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Proficient Rx LP | 28fda2ce-d445-47ce-8764-bf113b5db5b3 | 2022-11-01 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Documents#
| Document | Submission type | Date |
|---|---|---|
| 40113 | SUPPL | 2013-11-20 |
| 9953 | SUPPL | 2013-10-17 |
| 19055 | SUPPL | 2013-06-18 |
| 9952 | SUPPL | 2013-06-12 |
| 24405 | ORIG | 2013-05-24 |
| 22870 | ORIG | 2013-05-24 |
| 9951 | SUPPL | 2012-12-11 |
| 40112 | SUPPL | 2012-12-07 |
| 32172 | SUPPL | 2012-03-30 |
| 32171 | ORIG | 2012-03-29 |
| 40111 | ORIG | 2012-03-28 |
| 44842 | ORIG | 2012-03-09 |
| 22869 | ORIG | 2012-03-09 |
| 19054 | SUPPL | 2011-10-20 |
| 9950 | SUPPL | 2011-10-17 |
| 32170 | ORIG | 2011-06-16 |
| 19053 | ORIG | 2011-06-16 |