Application 061763

Type
ANDA
Sponsor
APOTHECON

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VELOSEF '125'CEPHRADINEFOR SUSPENSION;ORAL125MG/5MLNoNo
002VELOSEF '250'CEPHRADINEFOR SUSPENSION;ORAL250MG/5MLNoNo

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A061763-001VELOSEF '125'CEPHRADINE125MG/5MLFOR SUSPENSION / ORALApproved before 1982
A061763-002VELOSEF '250'CEPHRADINE250MG/5MLFOR SUSPENSION / 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 3 of 3 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A061763-001VELOSEF '125'125MG/5MLFOR SUSPENSION / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10A061763-002VELOSEF '250'250MG/5MLFOR SUSPENSION / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A061763-001VELOSEF '125'125MG/5MLFOR SUSPENSION / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09A061763-002VELOSEF '250'250MG/5MLFOR SUSPENSION / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061763-001VELOSEF '125'125MG/5MLFOR SUSPENSION / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A061763-002VELOSEF '250'250MG/5MLFOR SUSPENSION / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A061763-001VELOSEF '125'125MG/5MLFOR SUSPENSION / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A061763-002VELOSEF '250'250MG/5MLFOR SUSPENSION / ORALApproved before 1982a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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