FDA.reportPublic FDA data

Application 040555

Type
ANDA
Sponsor
LANNETT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDETABLET;ORAL37.5MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040555-001PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-1584e616aacf4f…
2026-08-18 06:07:402026-07A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-153f01610625f2…
2019-09-15 20:21 UTC2019-09A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORALAA2005-04-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040555-001PHENTERMINE HYDROCHLORIDE37.5MGTABLET / ORAL2005-04-15f41ea6bd6efb…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040555-001AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040555-001AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040555-001AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040555-001AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040555-001AA1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040555-001AA1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040555-001AA187673890dc5c…
2021-03-12 10:30 UTC2021-03A040555-001AA15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040555-001AA18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040555-001AA1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040555-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040555-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040555-001AA1ea99ee380514…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040555-001AA1cb3db0bc1861…

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.

Matched openFDA labels page 4 of 6 · 109 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.0b4d847a-fcda-df31-e063-6294a90a0c5e2025-02-03Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke08b4f49-de9f-490d-b11d-d865439f5fad2025-01-31Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack70f68311-8d1f-4b8e-b8a7-13bc4c17727e2025-01-31Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack86a6ce50-673d-4031-87a0-51965cc1e7952025-01-28Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepacke0a6a289-7dbf-4b24-b815-46dee0d19fdc2025-01-24Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack99c1325b-7152-481d-8a1f-6bf3e2c4808b2025-01-24Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack6b08ccd5-d01f-48f1-80a2-1d121f445d422025-01-23Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack5d84078d-ff2d-4800-b2f4-f1d30c8335bb2025-01-23Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDirectRxca683656-16a6-9602-e053-2a95a90aa8952025-01-20Warnings, Adverse reactionsName fallback
brand name: PHENTERMINE HYDROCHLORIDE
generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDirectRxd27d8379-aa3c-4688-e053-2995a90a44f62025-01-20Warnings, Adverse reactionsName fallback
brand name: PHENTERMINE HYDROCHLORIDE
generic name: PHENTERMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDIRECT RXc3dda0a4-b428-f3e7-e053-2995a90ad1062025-01-17Warnings, Adverse reactionsName fallback
brand name: PHENTERMINE HYDROCHLORIDE
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDESUNRISE PHARMACEUTICAL, INC.43024f64-2d77-49a9-80fd-ad07a86c69a32024-12-03Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack50efa498-11c5-41fa-95ac-419fcc10da032024-11-01Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackc8516abe-5ad1-4b76-8e2c-96ee455979cf2024-10-17Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HCLPHENTERMINE HYDROCHLORIDECalvin Scott & Co., Inc.8fe6b65d-ca61-40f0-90fc-255dfd0756112024-10-15Warnings, Adverse reactionsName fallback
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8abf898e-318b-3519-e053-2995a90abf2f2024-09-11Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine hydrochloridePHENTERMINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.1fa8798d-c096-5839-e063-6394a90aa28b2024-09-03Warnings, Adverse reactionsName fallback
brand name: Phentermine hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepack2bd5487d-10da-4ae0-9105-273e1a5efdcb2024-08-20Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackf427f067-f1a7-4d60-8ce0-90b20e2d4eb52024-08-20Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE
Phentermine HydrochloridePHENTERMINE HYDROCHLORIDEBryant Ranch Prepackf50f5453-e06d-4e39-b868-9bdadf1d8baa2024-08-20Warnings, Adverse reactionsName fallback
brand name: Phentermine Hydrochloride
generic name: PHENTERMINE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1445Phentermine HydrochloridePhentermine HydrochlorideLannett Company, Inc.ANDACurrent
0527-1445Phentermine HydrochloridePhentermine HydrochlorideLannett Company, Inc.ANDACurrent
0527-1445Phentermine HydrochloridePhentermine HydrochlorideLannett Company, Inc.ANDACurrent
0527-1445Phentermine HydrochloridePhentermine HydrochlorideLannett Company, Inc.ANDACurrent
17224-703Phentermine HydrochloridePhentermine HydrochlorideCALVIN, SCOTT AND COMPANY, INCORPORATEDANDACurrent
17224-703Phentermine HydrochloridePhentermine HydrochlorideCALVIN, SCOTT AND COMPANY, INCORPORATEDANDACurrent
43063-465Phentermine HydrochloridePhentermine HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50436-6744Phentermine HydrochloridePhentermine HydrochlorideUnit Dose ServicesANDACurrent
50436-6744Phentermine HydrochloridePhentermine HydrochlorideUnit Dose ServicesANDACurrent
51655-877Phentermine hydrochloridePhentermine hydrochlorideNorthwind PharmaceuticalsANDACurrent
53002-7930Phentermine HydrochloridePhentermine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53002-7930Phentermine HydrochloridePhentermine HydrochlorideRPK Pharmaceuticals, Inc.ANDACurrent
53217-171Phentermine HydrochloridePhentermine HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
61919-186PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-186PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDIRECT RXANDACurrent
61919-186PHENTERMINE HYDROCHLORIDEPHENTERMINE HYDROCHLORIDEDirect_RxANDACurrent
63187-515Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
63187-515Phentermine HydrochloridePhentermine HydrochlorideProficient Rx LPANDACurrent
68788-9271Phentermine HydrochloridePhentermine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9271Phentermine HydrochloridePhentermine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9271Phentermine HydrochloridePhentermine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9271Phentermine HydrochloridePhentermine HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
76420-057Phentermine HydrochloridePhentermine HydrochlorideAsclemed USA, Inc.ANDACurrent
76420-057Phentermine HydrochloridePhentermine HydrochlorideAsclemed USA, Inc.ANDACurrent
80425-0118Adipex-PPhentermine HCl 37.5mgAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0118Phentermine HCLPhentermine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent
80425-0118Phentermine HCLPhentermine HCLAdvanced Rx Pharmacy of Tennessee, LLCANDACurrent