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 1 of 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amphetamine SulfateAMPHETAMINE SULFATEAmici Pharma, Inc.e045dc28-e05d-4407-9d44-d0a11ca558e62026-07-21Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
Amphetamine SulfateAMPHETAMINE SULFATEGranules Pharmaceuticals Inc.26dbad66-13c4-4906-88b3-ab7ee191466c2026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
Amphetamine SulfateAMPHETAMINE SULFATEBryant Ranch Prepackb94e2562-fd19-455f-ac10-2cc24302d27a2026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
Amphetamine SulfateAMPHETAMINE SULFATEBryant Ranch Prepack920f99f4-ab78-4eed-9d80-08a2ebd0b7692026-03-30Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack9817a519-fdb0-474a-92f4-2e485c9cb0472026-02-04Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
Amphetamine SulfateAMPHETAMINE SULFATEEpic Pharma LLC432db708-91b7-4802-88c3-ceef597b91da2025-12-17Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
Amphetamine SulfateAMPHETAMINE SULFATEWilshire Pharmaceuticals, Inc.91add2e3-8359-47dc-b79f-197d36b028192025-10-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
EvekeoAMPHETAMINE SULFATEAzurity Pharmaceuticals, Inc.f469fb38-0380-4621-9db3-a4f4291261562025-10-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
Amphetamine SulfateAMPHETAMINE SULFATEBryant Ranch Prepack674940ec-1714-4e41-b471-2a8c8a6c5ade2025-08-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
Amphetamine SulfateAMPHETAMINE SULFATEBryant Ranch Prepackc972a6a4-a96c-4d70-b4c4-eef9e990abb42025-08-18Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
AMPHETAMINE SULFATEAMPHETAMINE SULFATESolco Healthcare US, LLC89c5b52f-3c2a-41d5-8624-9ee51c512c722025-05-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack9eb84b3c-2147-42dd-8053-6afd1a88b0c12025-02-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack3ad894e3-78a7-4e3b-80d1-1a925fb6d9e32024-04-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack698171ee-4328-476a-b71c-58aa6dc93b232024-04-05Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepackc00bbade-3dc8-422b-8cff-f85db408bdfc2024-04-02Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
Amphetamine SulfateAMPHETAMINE SULFATEAurolife Pharma, LLC20735c2e-6304-425f-a4e4-584f6f90d6a02024-01-29Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepackad4ce013-331b-4359-898f-bac97d64874f2024-01-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack7f16dd18-bf30-41ef-8981-932da5df09512024-01-25Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
AMPHETAMINE SULFATEAMPHETAMINE SULFATELannett Company, Inc.85a015a7-a1a0-4b04-8bc4-7aacd0c847422024-01-19Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE
AMPHETAMINE SULFATEAMPHETAMINE SULFATEBryant Ranch Prepack8f9341fc-4b95-4556-a51a-ea972fa6fccc2024-01-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: AMPHETAMINE SULFATE

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