FDA.reportPublic FDA data

Application 083900

Type
ANDA
Sponsor
SMITH KLINE & FRENCH

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001BENZEDRINEAMPHETAMINE SULFATETablet; Oral5MGNoNo
002BENZEDRINEAMPHETAMINE SULFATETablet; Oral10MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 2 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amphetamine SulfateAMPHETAMINE SULFATESpecGx LLC00242264-40d8-4267-a91a-727a1f0886162023-05-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE

Reported adverse events (FAERS/openFDA)#

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43187SUPPL2004-01-06
43186SUPPL2004-01-06
43185SUPPL2004-01-06
43184SUPPL2004-01-06
43183SUPPL2004-01-06
43182SUPPL2004-01-06
43181ORIG2004-01-06
22658SUPPL2004-01-06
22657SUPPL2004-01-06
22656SUPPL2004-01-06