Home Applications 021704 Application 021704
Type NDA
Sponsor SANOFI AVENTIS US Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE TABLET, EXTENDED RELEASE;ORAL 180MG;240MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021704-002 ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE 180MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-01-24
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 2 of 2 · 44 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 N021704-002 ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION 180MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-01-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021704-002 ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION 180MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-01-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021704-002 ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION 180MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-01-24 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N021704-002 ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION 180MG;240MG TABLET, EXTENDED RELEASE / ORAL RLD, RS 2011-01-24 a50c72e98297…
Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N021704-002 6613357 2020-12-25 U-1159 Drug product 2011-07-01 74a2ff9319b5…2020-12-22 03:56 UTC 2020-12 N021704-002 6613357 2020-12-25 U-1159 Drug product 2011-07-01 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021704-002 6613357 2020-12-25 U-1159 Drug product 2011-07-01 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021704-002 6613357 2020-12-25 U-1159 Drug product 2011-07-01 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021704-002 6613357 2020-12-25 U-1159 Drug product 2011-07-01 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021704-002 6613357 2020-12-25 U-1159 Drug product 2011-07-01 ea99ee380514…
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 · 4 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 41167-4320 Allegra-D Allergy and Congestion fexofenadine hydrochloride and pseudoephedrine hydrochloride Chattem, Inc. NDA Current 41167-4320 Allegra-D Allergy and Congestion fexofenadine hydrochloride and pseudoephedrine hydrochloride Chattem, Inc. NDA Current 41167-4320 Allegra-D Allergy and Congestion fexofenadine hydrochloride and pseudoephedrine hydrochloride Chattem, Inc. NDA Current 41167-4320 Allegra-D Allergy and Congestion fexofenadine hydrochloride and pseudoephedrine hydrochloride Chattem, Inc. NDA Current