FDA.reportPublic FDA data

Application 011673

Type
NDA
Sponsor
3M

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TEPANILDIETHYLPROPION HYDROCHLORIDETABLET;ORAL25MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N011673-001TEPANILDIETHYLPROPION HYDROCHLORIDE25MGTABLET / ORALApproved 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 table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N011673-001TEPANIL25MGTABLET / ORALApproved before 1982a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 22 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEA-S Medication Solutions04f1a804-00f1-48f5-acfa-0ed1a85447842026-05-29Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.ad0c3dc9-ae13-4853-bc8c-a66e2a69cc102025-10-15Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0d213a24-ebbf-41df-8f32-de44a572829e2025-10-15Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion HydrochlorideDIETHYLPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.5777eed8-c63d-49c4-9dd1-9d087906c3682025-10-02Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEOMNIVIUM PHARMACEUTICALS LLC.cd4f2b19-8752-4fed-81f3-d3074ade613c2025-09-19Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEMartek Pharmacal Co.130511dc-8f01-02ca-e063-6394a90a671b2025-07-21Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.335fb85d-8b1f-e648-e063-6294a90aa1582025-04-22Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDENuCare Pharmaceuticals, Inc.335265e0-1d5d-31fb-e063-6394a90a2e752025-04-21Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDECalvin Scott & Co., Inc.fa48ad75-4fc8-4355-a19d-cd1b9d87f5532025-02-27Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDECalvin Scott & Co., Inc.d6cde8cc-26ae-4087-8eac-b11192749cc52025-02-25Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDENuCare Pharmaceuticals,Inc.fe7e5022-8b58-aa4f-e053-6294a90af65e2025-02-04Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion HydrochlorideDIETHYLPROPION HYDROCHLORIDEA-S Medication Solutions7f4eca5b-f850-44fc-88b4-4d9bcdf2ba442025-01-22Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion HydrochlorideDIETHYLPROPION HYDROCHLORIDEChartwell RX, LLC.b8984c2d-244e-4c56-be3e-c402dc679b1f2024-10-10Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEChartwell RX, LLC.fdb6e69c-4f8e-42d8-bdda-c99ff3ad7c1e2024-10-10Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion HydrochlorideDIETHYLPROPION HYDROCHLORIDEBryant Ranch Prepack54655904-7ce2-49d5-9acf-81ad9680d2152024-10-02Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEBryant Ranch Prepackfb8e2f1b-24ef-4e1d-a493-4c3b3de05b262024-08-07Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEBryant Ranch Prepack89306917-a65b-40d4-9c51-d59ac0ad20172024-08-07Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDEKVK-TECH, INC3ecb7bd7-e04c-47fe-859a-8ba8a54f9aff2024-05-01Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDELannett Company, Inc.dab53f4f-68d4-4477-a2b6-ad44a956332b2022-07-27Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE
Diethylpropion HydrochlorideDIETHYLPROPION HYDROCHLORIDEProficient Rx LP2a2fbc1b-6430-485b-b581-10fbfca0af882020-10-01Warnings, Adverse reactionsName fallback
generic name: DIETHYLPROPION HYDROCHLORIDE