FDA.reportPublic FDA data

Application 012546

Type
NDA
Sponsor
NOSTRUM LABS INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TENUATE DOSPANDIETHYLPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL75MGYesNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
N012546-001TENUATE DOSPANDIETHYLPROPION HYDROCHLORIDE75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982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.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N012546-001TENUATE DOSPAN75MGTABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N012546-001TENUATE DOSPAN75MGTABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012546-001TENUATE DOSPAN75MGTABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N012546-001TENUATE DOSPAN75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, EXTENDED RELEASE / ORALRLD, Approved before 1982a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-07-19 19:46 UTC2019-07N012546-001AB1ea99ee380514…

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 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

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 · 7 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0591-0782Diethylpropion HCl Controlled-ReleaseDiethylpropion hydrochlorideActavis Pharma, Inc.NDACurrent
12634-691diethylpropion hydrochloride erdiethylpropion hydrochloride erApotheca Inc.NDACurrent
50090-0121Diethylpropion HCl Controlled-ReleaseDiethylpropion hydrochlorideA-S Medication SolutionsNDACurrent
63629-2967Diethylpropion HClDiethylpropion hydrochlorideBryant Ranch PrepackNDACurrent
66267-077Diethylpropion HCl Controlled-ReleaseDiethylpropion hydrochlorideNuCare Pharmaceuticals, Inc.NDACurrent
66267-077Diethylpropion HCl Controlled-ReleaseDiethylpropion hydrochlorideNuCare Pharmaceuticals, Inc.NDACurrent
68788-0686Diethylpropion HCl Controlled-ReleaseDiethylpropion hydrochloridePreferred Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
12020SUPPL2004-09-07
10814SUPPL2004-09-07