Home Applications 011145 Application 011145
Type NDA
Sponsor OAK PHARMS AKORN Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 DIURIL CHLOROTHIAZIDE TABLET;ORAL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 004 DIURIL CHLOROTHIAZIDE TABLET;ORAL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No 005 DIURIL CHLOROTHIAZIDE SODIUM INJECTABLE;INJECTION EQ 500MG BASE/VIAL Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N011145-002 DIURIL CHLOROTHIAZIDE 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 N011145-004 DIURIL CHLOROTHIAZIDE 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 N011145-005 DIURIL CHLOROTHIAZIDE SODIUM EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 N011145-002 DIURIL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N011145-004 DIURIL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N011145-005 DIURIL EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N011145-002 DIURIL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N011145-004 DIURIL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N011145-005 DIURIL EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N011145-002 DIURIL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N011145-004 DIURIL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N011145-005 DIURIL EQ 500MG BASE/VIAL INJECTABLE / INJECTION AP RLD, RS, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N011145-002 DIURIL 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N011145-004 DIURIL 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N011145-005 DIURIL EQ 500MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** INJECTABLE / INJECTION RLD, Approved before 1982 a50c72e98297…
Observed Orange Book normalized TE history# 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 1 · 1 matching rows.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 17478-419 Chlorothiazide Sodium Chlorothiazide Sodium Akorn, Inc. NDA AUTHORIZED GENERIC Current 17478-419 Chlorothiazide Sodium Chlorothiazide Sodium Akorn NDA AUTHORIZED GENERIC Current 17478-419 Chlorothiazide Sodium Chlorothiazide Sodium Akorn NDA AUTHORIZED GENERIC Current 17478-419 Chlorothiazide Sodium Chlorothiazide Sodium Akorn, Inc. NDA AUTHORIZED GENERIC Current 17478-419 Chlorothiazide Sodium Chlorothiazide Sodium Akorn, Inc. NDA AUTHORIZED GENERIC Current 76478-711 Sodium Diuril chlorothiazide sodium Akorn NDA Current 76478-711 Sodium Diuril chlorothiazide sodium Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) NDA Current 76478-711 Sodium Diuril chlorothiazide sodium Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) NDA Current 76478-711 Sodium Diuril chlorothiazide sodium Akorn NDA Current 76478-711 Sodium Diuril chlorothiazide sodium Oak Pharmaceuticals, Inc. (Subsidiary of Akorn, Inc.) NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 252 SUPPL 2005-08-11 251 SUPPL 2004-10-29 11922 SUPPL 2004-09-29 250 SUPPL 2004-09-29