FDA.reportPublic FDA data

Application 010093

Type
NDA
Sponsor
UCB INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
003BIPHETAMINE 20AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEXCAPSULE, EXTENDED RELEASE;ORALEQ 10MG BASE;EQ 10MG BASENoNo
007BIPHETAMINE 12.5AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEXCAPSULE, EXTENDED RELEASE;ORALEQ 6.25MG BASE;EQ 6.25MG BASENoNo
009BIPHETAMINE 7.5AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEXCAPSULE, EXTENDED RELEASE;ORALEQ 3.75MG BASE;EQ 3.75MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N010093-003BIPHETAMINE 20AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEXEQ 10MG BASE;EQ 10MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982
N010093-007BIPHETAMINE 12.5AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEXEQ 6.25MG BASE;EQ 6.25MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982
N010093-009BIPHETAMINE 7.5AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEXEQ 3.75MG BASE;EQ 3.75MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982

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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N010093-003BIPHETAMINE 20EQ 10MG BASE;EQ 10MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N010093-007BIPHETAMINE 12.5EQ 6.25MG BASE;EQ 6.25MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N010093-009BIPHETAMINE 7.5EQ 3.75MG BASE;EQ 3.75MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N010093-003BIPHETAMINE 20EQ 10MG BASE;EQ 10MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N010093-007BIPHETAMINE 12.5EQ 6.25MG BASE;EQ 6.25MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N010093-009BIPHETAMINE 7.5EQ 3.75MG BASE;EQ 3.75MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N010093-003BIPHETAMINE 20EQ 10MG BASE;EQ 10MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N010093-007BIPHETAMINE 12.5EQ 6.25MG BASE;EQ 6.25MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N010093-009BIPHETAMINE 7.5EQ 3.75MG BASE;EQ 3.75MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N010093-003BIPHETAMINE 20EQ 10MG BASE;EQ 10MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N010093-007BIPHETAMINE 12.5EQ 6.25MG BASE;EQ 6.25MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N010093-009BIPHETAMINE 7.5EQ 3.75MG BASE;EQ 3.75MG BASECAPSULE, EXTENDED RELEASE / ORALApproved before 1982a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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