FDA.reportPublic FDA data

Application 040845

Type
ANDA
Sponsor
IMPAX LABS

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDETABLET;ORAL50MGNoNo

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
A040845-001BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2008-11-18

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 22:54:322026-06A040845-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2008-11-18a50c72e98297…

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDEKVK-TECH, INC14d4589d-7f1c-4b6e-9557-59dad39b09602026-07-29Warnings, Adverse reactionsName fallback
brand name: BENZPHETAMINE HYDROCHLORIDE
generic name: BENZPHETAMINE HYDROCHLORIDE
Benzphetamine HydrochlorideBENZPHETAMINE HYDROCHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.152a123e-4886-4184-a47d-462ce102b8fa2026-06-18Warnings, Adverse reactionsName fallback
brand name: Benzphetamine Hydrochloride
generic name: BENZPHETAMINE HYDROCHLORIDE
BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.2b7014af-0cc9-4199-90f2-ec07ac02f8cf2025-10-15Warnings, Adverse reactionsName fallback
brand name: BENZPHETAMINE HYDROCHLORIDE
generic name: BENZPHETAMINE HYDROCHLORIDE
BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDEBryant Ranch Prepack1c726aa7-3b78-45de-aca0-fd8a5fff94032024-05-29Warnings, Adverse reactionsName fallback
brand name: BENZPHETAMINE HYDROCHLORIDE
generic name: BENZPHETAMINE HYDROCHLORIDE
Benzphetamine HydrochlorideBENZPHETAMINE HYDROCHLORIDEEpic Pharma, LLCf6d9b369-4b64-4d3f-844d-5d60dd257c552023-12-27Warnings, Adverse reactionsName fallback
brand name: Benzphetamine Hydrochloride
generic name: BENZPHETAMINE HYDROCHLORIDE
benzphetamine hydrochlorideBENZPHETAMINE HYDROCHLORIDECalvin Scott & Co., Inc.f5c3c2ed-54a2-1def-e053-2995a90ab4e32023-03-02Warnings, Adverse reactionsName fallback
brand name: benzphetamine hydrochloride
generic name: BENZPHETAMINE HYDROCHLORIDE

NDC Listings For This Application#

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

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
63629-4139Benzphetamine HydrochlorideBenzphetamine Hydrochloridebryant ranch prepackANDACurrent