Application 017352
- Type
- NDA
- Sponsor
- GLAXOSMITHKLINE
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | FASTIN | PHENTERMINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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 |
|---|---|---|---|---|---|---|---|
| N017352-001 | FASTIN | PHENTERMINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 |
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| 2026-08 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N017352-001 | FASTIN | 30MG | CAPSULE / ORAL | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N017352-001 | FASTIN | 30MG | CAPSULE / ORAL | Approved before 1982 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | Approved before 1982 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | Approved before 1982 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | Approved before 1982 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | Approved before 1982 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | Approved before 1982 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | Approved before 1982 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | Approved before 1982 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | Approved before 1982 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CAPSULE / ORAL | Approved before 1982 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 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 | NuCare Pharmaceuticals,Inc. | 0b4d847a-fcda-df31-e063-6294a90a0c5e | 2025-02-03 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | e08b4f49-de9f-490d-b11d-d865439f5fad | 2025-01-31 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 70f68311-8d1f-4b8e-b8a7-13bc4c17727e | 2025-01-31 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 86a6ce50-673d-4031-87a0-51965cc1e795 | 2025-01-28 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | e0a6a289-7dbf-4b24-b815-46dee0d19fdc | 2025-01-24 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 99c1325b-7152-481d-8a1f-6bf3e2c4808b | 2025-01-24 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 6b08ccd5-d01f-48f1-80a2-1d121f445d42 | 2025-01-23 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 5d84078d-ff2d-4800-b2f4-f1d30c8335bb | 2025-01-23 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | DirectRx | ca683656-16a6-9602-e053-2a95a90aa895 | 2025-01-20 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | DirectRx | d27d8379-aa3c-4688-e053-2995a90a44f6 | 2025-01-20 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| PHENTERMINE HYDROCHLORIDE | PHENTERMINE HYDROCHLORIDE | DIRECT RX | c3dda0a4-b428-f3e7-e053-2995a90ad106 | 2025-01-17 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | SUNRISE PHARMACEUTICAL, INC. | 43024f64-2d77-49a9-80fd-ad07a86c69a3 | 2024-12-03 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 50efa498-11c5-41fa-95ac-419fcc10da03 | 2024-11-01 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | c8516abe-5ad1-4b76-8e2c-96ee455979cf | 2024-10-17 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine HCL | PHENTERMINE HYDROCHLORIDE | Calvin Scott & Co., Inc. | 8fe6b65d-ca61-40f0-90fc-255dfd075611 | 2024-10-15 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 8abf898e-318b-3519-e053-2995a90abf2f | 2024-09-11 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 1fa8798d-c096-5839-e063-6394a90aa28b | 2024-09-03 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 2bd5487d-10da-4ae0-9105-273e1a5efdcb | 2024-08-20 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | f427f067-f1a7-4d60-8ce0-90b20e2d4eb5 | 2024-08-20 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | f50f5453-e06d-4e39-b868-9bdadf1d8baa | 2024-08-20 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.