FDA.reportPublic FDA data

Application 090818

Type
ANDA
Sponsor
SUN PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL60MG;120MGNoNo

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
A090818-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2015-01-29

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 UTC2022-10A090818-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2015-01-29f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090818-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2015-01-29e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090818-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2015-01-29cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090818-001FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE60MG;120MGTABLET, EXTENDED RELEASE / ORAL2015-01-29a50c72e98297…

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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEAmeriSource Bergen4a8df3c9-bed3-4371-a1c1-59afe12203e22025-11-14WarningsExact identifier
application applno (ANDA): 090818
application number: ANDA090818
ndc (product): 46122-694
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.87ab4578-84de-475d-a4b0-eec969f172532025-11-13WarningsExact identifier
application applno (ANDA): 090818
application number: ANDA090818
ndc (product): 51660-037
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.8afc0167-17bf-4ccd-91c9-8fb9c4e241c12025-03-11WarningsExact identifier
application applno (ANDA): 090818
application number: ANDA090818
ndc (product): 47335-724
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEPUBLIX SUPER MARKETS, INC75236b23-af51-40b6-ad1b-f62a27093a162024-10-10WarningsExact identifier
application applno (ANDA): 090818
application number: ANDA090818
ndc (product): 41415-995
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEwalgreens1ed05c85-7a1c-440d-a5d7-e229528cedcd2024-05-28WarningsExact identifier
application applno (ANDA): 090818
application number: ANDA090818
ndc (product): 0363-2110
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy45d3ad69-a80a-4f91-9c9b-8b19a30144a32024-04-26WarningsExact identifier
application applno (ANDA): 090818
application number: ANDA090818
ndc (product): 69842-973
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEH E B5167ab78-f898-47ec-8baf-843269469d102018-07-18WarningsExact identifier
application applno (ANDA): 090818
application number: ANDA090818
ndc (product): 37808-999
Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS Pharmacy02476e5a-0463-4223-8dc5-8bbe787d38dc2018-05-31WarningsExact identifier
application applno (ANDA): 090818
application number: ANDA090818
ndc (product): 69842-990

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-2110Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochloridewalgreensANDACurrent
37808-999Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideH E BANDACurrent
41415-995Fexofenadine Hydrochloride and Pseudoephedrine Hydrochloridefexofenadine hydrochloride and pseudoephedrine hydrochloridePUBLIX SUPER MARKETS, INCANDACurrent
46122-452Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideAmeriSource BergenANDACurrent
46122-694Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideAmeriSource BergenANDACurrent
47335-724Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
51660-037Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideOhm Laboratories Inc.ANDACurrent
56062-999Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochloridePUBLIX SUPER MARKETS INCANDACurrent
56062-999Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochloridePUBLIX SUPER MARKETS INCANDACurrent
69842-973Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS PharmacyANDACurrent
69842-990Fexofenadine Hydrochloride and Pseudoephedrine HydrochlorideFexofenadine Hydrochloride and Pseudoephedrine HydrochlorideCVS PharmacyANDACurrent