FDA.reportPublic FDA data

Application 091680

Type
ANDA
Sponsor
LANNETT CO INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL75MGNoYes

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
A091680-001DIETHYLPROPION HYDROCHLORIDEDIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24

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 22:54:322026-06A091680-001DIETHYLPROPION HYDROCHLORIDE75MGTABLET, EXTENDED RELEASE / ORALRS2011-10-24a50c72e98297…

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 1 · 10 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 reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
ndc (product): 50090-0120
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.0d213a24-ebbf-41df-8f32-de44a572829e2025-10-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
ndc (product): 43063-532
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEOMNIVIUM PHARMACEUTICALS LLC.cd4f2b19-8752-4fed-81f3-d3074ade613c2025-09-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDENuCare Pharmaceuticals, Inc.335265e0-1d5d-31fb-e063-6394a90a2e752025-04-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDECalvin Scott & Co., Inc.d6cde8cc-26ae-4087-8eac-b11192749cc52025-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
DIETHYLPROPION HYDROCHLORIDE ERDIETHYLPROPION HYDROCHLORIDE ERDirectrxd44e23db-381a-cfc3-e053-2995a90a13c82025-01-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
ndc (product): 72189-307
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEChartwell RX, LLC.fdb6e69c-4f8e-42d8-bdda-c99ff3ad7c1e2024-10-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEBryant Ranch Prepack89306917-a65b-40d4-9c51-d59ac0ad20172024-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
ndc (product): 71335-0049
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDELannett Company, Inc.dab53f4f-68d4-4477-a2b6-ad44a956332b2022-07-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
ndc (product): 0527-1477
Diethylpropion Hydrochloride ERDIETHYLPROPION HYDROCHLORIDEProficient Rx LP15110f70-6602-4e05-a4b5-716a86dcaed52019-11-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 091680
application number: ANDA091680
ndc (product): 63187-621

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 28 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0527-1477Diethylpropion HydrochlorideDiethylpropion HydrochlorideLannett Company, Inc.ANDACurrent
0527-1477Diethylpropion HydrochlorideDiethylpropion HydrochlorideLannett Company, Inc.ANDACurrent
0527-1477Diethylpropion HydrochlorideDiethylpropion HydrochlorideLannett Company, Inc.ANDACurrent
0527-1477Diethylpropion HydrochlorideDiethylpropion HydrochlorideLannett Company, Inc.ANDACurrent
17224-360Diethylpropion HydrochlorideDiethylpropion HydrochlorideCALVIN, SCOTT AND COMPANY, INCORPORATEDANDACurrent
17224-360Diethylpropion HydrochlorideDiethylpropion HydrochlorideCALVIN, SCOTT AND COMPANY, INCORPORATEDANDACurrent
33261-354Diethylpropion HydrochlorideERDiethylpropion HydrochlorideAidarex Pharmaceuticals LLCANDACurrent
43063-532Diethylpropion HydrochlorideDiethylpropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-532Diethylpropion HydrochlorideDiethylpropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-532Diethylpropion HydrochlorideDiethylpropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-532Diethylpropion HydrochlorideDiethylpropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-532Diethylpropion HydrochlorideDiethylpropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
43063-532Diethylpropion HydrochlorideDiethylpropion HydrochloridePD-Rx Pharmaceuticals, Inc.ANDACurrent
50090-0120Diethylpropion HydrochlorideDiethylpropion HydrochlorideA-S Medication SolutionsANDACurrent
50090-0120Diethylpropion HydrochlorideDiethylpropion HydrochlorideA-S Medication SolutionsANDACurrent
50090-0120Diethylpropion HydrochlorideDiethylpropion HydrochlorideA-S Medication SolutionsANDACurrent
50090-0120Diethylpropion HydrochlorideDiethylpropion HydrochlorideA-S Medication SolutionsANDACurrent
50090-0120Diethylpropion HydrochlorideDiethylpropion HydrochlorideA-S Medication SolutionsANDACurrent
52959-329Diethylpropion HydrochlorideDiethylpropion HydrochlorideH.J. Harkins Company, Inc.ANDACurrent
63187-621Diethylpropion HydrochlorideDiethylpropion HydrochlorideProficient Rx LPANDACurrent
63187-621Diethylpropion HydrochlorideDiethylpropion HydrochlorideProficient Rx LPANDACurrent
68788-9423Diethylpropion HydrochlorideDiethylpropion HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9423Diethylpropion HydrochlorideDiethylpropion HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
68788-9423Diethylpropion HydrochlorideDiethylpropion HydrochloridePreferred Pharmaceuticals, Inc.ANDACurrent
71335-0049Diethylpropion HydrochlorideDiethylpropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0049Diethylpropion HydrochlorideDiethylpropion HydrochlorideBryant Ranch PrepackANDACurrent
71335-0049Diethylpropion HydrochlorideDiethylpropion HydrochlorideBryant Ranch PrepackANDACurrent
72189-307DIETHYLPROPION HYDROCHLORIDE ERDIETHYLPROPION HYDROCHLORIDE ERDirectrxANDACurrent