Home Applications 012806 Application 012806
Type NDA
Sponsor ALMIRALL Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CORDRAN FLURANDRENOLIDE OINTMENT;TOPICAL 0.05% Yes Yes 002 CORDRAN SP FLURANDRENOLIDE CREAM;TOPICAL 0.05% Yes Yes 003 CORDRAN SP FLURANDRENOLIDE CREAM;TOPICAL 0.025% Yes Yes 004 CORDRAN FLURANDRENOLIDE OINTMENT;TOPICAL 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Yes No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N012806-001 CORDRAN FLURANDRENOLIDE 0.05% OINTMENT / TOPICAL RLD, Approved before 1982 N012806-002 CORDRAN SP FLURANDRENOLIDE 0.05% CREAM / TOPICAL RLD, Approved before 1982 N012806-003 CORDRAN SP FLURANDRENOLIDE 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD, Approved before 1982 N012806-004 CORDRAN FLURANDRENOLIDE 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / TOPICAL RLD, Approved before 1982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 5 of 5 · 176 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 N012806-001 CORDRAN 0.05% OINTMENT / TOPICAL AT RLD, RS, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N012806-002 CORDRAN SP 0.05% CREAM / TOPICAL RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N012806-003 CORDRAN SP 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD, Approved before 1982 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 N012806-004 CORDRAN 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / TOPICAL RLD, Approved before 1982 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N012806-001 CORDRAN 0.05% OINTMENT / TOPICAL AT RLD, RS, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N012806-002 CORDRAN SP 0.05% CREAM / TOPICAL RLD, RS, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N012806-003 CORDRAN SP 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD, Approved before 1982 e64feba35796…2022-09-29 23:25 UTC 2022-09 N012806-004 CORDRAN 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / TOPICAL RLD, Approved before 1982 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N012806-001 CORDRAN 0.05% OINTMENT / TOPICAL AT RLD, RS, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N012806-002 CORDRAN SP 0.05% CREAM / TOPICAL RLD, RS, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N012806-003 CORDRAN SP 0.025% CREAM / TOPICAL RLD, Approved before 1982 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N012806-004 CORDRAN 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / TOPICAL RLD, Approved before 1982 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N012806-001 CORDRAN 0.05% OINTMENT / TOPICAL RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N012806-002 CORDRAN SP 0.05% CREAM / TOPICAL RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N012806-003 CORDRAN SP 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** CREAM / TOPICAL RLD, Approved before 1982 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N012806-004 CORDRAN 0.025% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** OINTMENT / TOPICAL 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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CORDRAN FLURANDRENOLIDE INA Pharmaceutics, Inc 39c0d1e6-6816-7ae5-e063-6394a90a592e 2025-07-07 Adverse reactions Exact identifier application applno (NDA): 012806 application number: NDA012806
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 16110-026 Cordran flurandrenolide Almirall, LLC NDA Current 16110-026 Cordran flurandrenolide Aqua Pharmaceuticals NDA Current 16110-026 Cordran flurandrenolide Almirall, LLC NDA Current 16110-034 Cordran flurandrenolide Almirall, LLC NDA Current 16110-034 Cordran flurandrenolide Aqua Pharmaceuticals NDA Current 16110-034 Cordran flurandrenolide Almirall, LLC NDA Current 16110-035 Cordran flurandrenolide Almirall, LLC NDA Current 16110-035 Cordran flurandrenolide Aqua Pharmaceuticals NDA Current 16110-035 Cordran flurandrenolide Almirall, LLC NDA Current 51672-5301 Flurandrenolide Flurandrenolide Taro Pharmaceuticals U.S.A., Inc. NDA Current
Documents# Document, Submission type, Date table Document Submission type Date 10824 SUPPL 2013-07-30 343 SUPPL 2013-06-14 12037 SUPPL 2002-07-17