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| PHENTERMINE HYDROCHLORIDE | CAPSULE;ORAL | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | No | No |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| FASTIN | PHENTERMINE HYDROCHLORIDE | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 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UTC | 2026-02 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 011fe1cb6892… | ||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this ZIP | 2025-12 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 31067a03dcf5… | ||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UTC | 2025-08 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | 6a471c1ec25d… | ||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this ZIP | 2025-03 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | fd3edfee7708… | ||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… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N017352-001 | FASTIN | 30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CAPSULE / ORAL | Approved before 1982 | cb3db0bc1861… |
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. | d77f31b4-7e36-4a0a-a55b-78b4b6ab5cb7 | 2025-09-09 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine hydrochloride | PHENTERMINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 129e781c-5366-4986-8e67-6b35fa4c3f39 | 2025-09-09 | Warnings, Adverse reactions | PHENTERMINE HYDROCHLORIDE |
| Phentermine Hydrochloride | PHENTERMINE HYDROCHLORIDE | Preferred Pharmaceuticals, Inc. | 70bc6f36-8087-4ccd-a396-a911c0ebae79 | 2025-09-08 | 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 |