FDA.reportPublic FDA data

Application 020786

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002ALLEGRA-D 12 HOUR ALLERGY AND CONGESTIONFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL60MG;120MGYesYes

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020786-002ALLEGRA-D 12 HOUR ALLERGY AND CONGESTIONFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2011-01-24

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020786-002ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION60MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2011-01-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020786-002ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION60MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2011-01-24e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020786-002ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION60MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2011-01-24cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020786-002ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION60MG;120MGTABLET, EXTENDED RELEASE / ORALRLD, RS2011-01-24a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allegra-D Allergy and CongestionFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEChattem, Inc.b32e172a-abf5-4c17-aa39-19e517952b912026-01-12WarningsExact identifier
application applno (NDA): 020786
application number: NDA020786
ndc (product): 41167-4310
ALLEGRA-DFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEA-S Medication Solutions705e1087-61cb-43c3-8675-f56626a1707b2024-01-07WarningsExact identifier
application applno (NDA): 020786
application number: NDA020786
ndc (product): 50090-1203

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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
21695-820FEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE and PSEUDOEPHEDRINE HYDROCHLORIDERebel Distributors CorpNDACurrent
21695-931Allegra D 12 Hour Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochlorideRebel Distributors CorpNDACurrent
41167-4310Allegra-D Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochlorideChattem, Inc.NDACurrent
41167-4310Allegra-D Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochlorideChattem, Inc.NDACurrent
41167-4310Allegra-D Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochlorideChattem, Inc.NDACurrent
41167-4310Allegra-D Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochlorideChattem, Inc.NDACurrent
50090-1203Allegra-D Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochlorideA-S Medication SolutionsNDACurrent
50090-1203Allegra-D Allergy and Congestionfexofenadine hydrochloride and pseudoephedrine hydrochlorideA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
35361SUPPL2016-06-10
3362SUPPL2016-06-07
13441SUPPL2015-06-19
25841SUPPL2015-06-10
13440SUPPL2013-01-08
3361SUPPL2012-12-11
35360SUPPL2012-10-12
3360SUPPL2012-08-27
35359SUPPL2012-03-27
3359SUPPL2012-02-13
25840SUPPL2011-01-27
41701ORIG2010-05-25
13439SUPPL2010-04-19
3358SUPPL2010-04-19
41705SUPPL2008-08-08
41703SUPPL2008-08-08
41702SUPPL2008-08-08
20954SUPPL2008-08-08
41707SUPPL2008-08-04
41706SUPPL2008-08-04
41704SUPPL2008-08-04
20955SUPPL2007-08-06
3357SUPPL2003-06-08
13438SUPPL2003-05-29
3356SUPPL2002-11-01