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| TABLET, ORALLY DISINTEGRATING;ORAL | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| TABLET, ORALLY DISINTEGRATING;ORAL | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| SUPRENZA | PHENTERMINE HYDROCHLORIDE | 15MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | ||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| SUPRENZA | PHENTERMINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2011-06-13 | ||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| SUPRENZA | PHENTERMINE HYDROCHLORIDE | 37.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET, ORALLY DISINTEGRATING / ORAL | 2012-03-27 |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 | A-S Medication Solutions | 5234cabd-6b3e-404d-a0cd-256ee5fcc8f1 | 2025-10-08 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | A-S Medication Solutions | 7198d596-3e1c-49d5-91aa-c62fa2e2b800 | 2025-10-08 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 640d71d8-45c9-42fb-ad96-2f3ac60afc9c | 2025-09-05 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | fe78b5b4-47bf-484b-ab37-e0d7de6fad57 | 2025-09-05 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | e4508aa9-1e7a-4af7-829e-5fa353c92f5e | 2025-08-22 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Chartwell RX, LLC | d70f0be3-fcc7-4a1d-9a82-bb1bb21a1528 | 2025-08-19 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Martek Pharmacal Co. | c4e9ec2e-4660-4442-93d7-c05a16e137b5 | 2025-07-23 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Martek Pharmacal Co. | 12699287-9ca9-07b3-e063-6294a90af21a | 2025-07-23 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Martek Pharmacal Co. | 1fe86035-19ef-4944-ad81-c0167a8e7fec | 2025-07-23 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Martek Pharmacal Co. | 1a8b3c4a-f7fe-5cc9-e063-6394a90a90dd | 2025-07-21 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | 02b8f684-b1ca-4ab7-9567-bcacc6a92779 | 2025-07-14 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | SUNRISE PHARMACEUTICAL, INC. | a0439c85-5ede-4e02-aed2-47debd2c8eb2 | 2025-07-08 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 723c37c4-868f-40f0-b74d-137dcbb93f9f | 2025-06-02 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | a1bca4b5-df64-4bac-a3a2-67f5c1eddbce | 2025-05-12 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Calvin Scott & Co., Inc. | f3b43443-dcf3-4a0d-a919-1be1bb9495ed | 2025-04-24 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 315b8a94-b7cc-1b47-e063-6294a90a2d39 | 2025-03-27 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 312d9742-6a65-c1cb-e063-6394a90a2e66 | 2025-03-25 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 30b48126-45f3-21fa-e063-6294a90a968f | 2025-03-19 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Solco Healthcare U.S., LLC | e4024b8a-25cb-4681-9bb4-44a38c74fe4b | 2025-03-06 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Calvin Scott & Co., Inc. | 2d7ddbc2-2afc-473e-a73b-b44ab9fcfaab | 2025-02-26 | 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 |