Application 012265

Type
NDA
Sponsor
SCHERING

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001NAQUATRICHLORMETHIAZIDETABLET;ORAL2MGNoNo
002NAQUATRICHLORMETHIAZIDETABLET;ORAL4MGNoNo
003NAQUIVALRESERPINE; TRICHLORMETHIAZIDETABLET;ORAL0.1MG;4MGNoNo

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
N012265-001NAQUATRICHLORMETHIAZIDE2MGTABLET / ORALApproved before 1982
N012265-002NAQUATRICHLORMETHIAZIDE4MGTABLET / ORALApproved before 1982
N012265-003NAQUIVALRESERPINE; TRICHLORMETHIAZIDE0.1MG;4MGTABLET / 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 UTC2022-10N012265-001NAQUA2MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N012265-002NAQUA4MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N012265-003NAQUIVAL0.1MG;4MGTABLET / ORALApproved before 1982f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N012265-001NAQUA2MGTABLET / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N012265-002NAQUA4MGTABLET / ORALApproved before 1982e64feba35796…
2022-09-29 23:25 UTC2022-09N012265-003NAQUIVAL0.1MG;4MGTABLET / ORALApproved before 1982e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012265-001NAQUA2MGTABLET / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012265-002NAQUA4MGTABLET / ORALApproved before 1982cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N012265-003NAQUIVAL0.1MG;4MGTABLET / ORALApproved before 1982cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N012265-001NAQUA2MGTABLET / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N012265-002NAQUA4MGTABLET / ORALApproved before 1982a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N012265-003NAQUIVAL0.1MG;4MGTABLET / ORALApproved before 1982a50c72e98297…

Reported adverse events (FAERS/openFDA)#

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