FDA.reportPublic FDA data

Application 040773

Type
ANDA
Sponsor
SPECGX LLC

Application Products#

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

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
A040773-001BENZPHETAMINE HYDROCHLORIDEBENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-04-25

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 UTC2022-10A040773-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-04-25f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040773-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-04-25e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040773-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-04-25cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A040773-001BENZPHETAMINE HYDROCHLORIDE50MGTABLET / ORAL2007-04-25a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040773-001AA174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A040773-001AA13f01610625f2…
2019-09-15 20:21 UTC2019-09A040773-001AA1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040773-001AA1ea99ee380514…

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 1 · 5 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 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

Reported adverse events (FAERS/openFDA)#

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