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| PHENTERMINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| FASTIN | PHENTERMINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 |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| 2026-08 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 84e616aacf4f… | ||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| 2026-07 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | caaa826d4ba7… | ||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UTC | 2026-02 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||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this ZIP | 2025-12 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||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 | Calvin Scott & Co., Inc. | aa9d7161-cda3-4ded-8d5b-424abd1a6681 | 2026-02-05 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | fa5de92d-a5bf-4ae1-8e13-ad827aeebea3 | 2026-02-04 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | A-S Medication Solutions | 86ec6b9d-2934-4bad-8a80-0b60e2f912f3 | 2026-01-24 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | A-S Medication Solutions | ea798229-fc2d-417c-9bc9-a3b942f0b64b | 2026-01-23 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | A-S Medication Solutions | 0e893b62-bb07-4984-9f0a-3601435fbc27 | 2026-01-22 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Martek Pharmacal Co. | 1149f69d-65df-6a98-e063-6394a90aeaa4 | 2026-01-22 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | 4686bc8d-7173-477e-96c8-a7d33653df2e | 2026-01-07 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | d76940d3-95e6-442d-99ef-4fe92de7a376 | 2025-12-29 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Northwind Health Company, LLC | 1b5396a8-e7ef-45ae-e063-6294a90a14a2 | 2025-12-26 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | TAGI Pharma, Inc. | 1993b181-f4f1-4451-92a0-7ed8f32598ba | 2025-12-23 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Precision Dose Inc. | 8d5697b9-02e8-40c4-97c7-761d635243c8 | 2025-12-16 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Precision Dose Inc. | 095a2be5-721e-46e6-976f-9137c855cd22 | 2025-12-02 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Bryant Ranch Prepack | a9270c14-499f-4c07-a1eb-c0aab5d8731f | 2025-10-29 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 6749c074-52a1-4d74-96a2-d9302b3c49a1 | 2025-10-20 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 68fcc228-5f06-4ece-94f3-59b5b33c3325 | 2025-10-20 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 4000c00f-aa6c-4ea5-af0e-149dde3c74db | 2025-10-20 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f115ad6d-cf62-40e7-89d1-6183a9b5071f | 2025-10-17 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 378d863a-6977-4543-ae50-c3684a6abd9b | 2025-10-15 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | abf702d6-6f94-48dc-ad23-c52fd74e83a8 | 2025-10-15 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 2abc445c-daa8-7326-e054-00144ff88e88 | 2025-10-15 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.