FDA.reportPublic FDA data

Application 079043

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL180MG;240MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A079043-002FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEFEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2011-06-22

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-09-29 23:25 UTC2022-09A079043-002FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2011-06-22e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079043-002FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2011-06-22cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A079043-002FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE180MG;240MGTABLET, EXTENDED RELEASE / ORAL2011-06-22a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Fexofenadine HCl and Pseudoephedrine HCIFEXOFENADINE HCL AND PSEUDOEPHEDRINE HCIDr.Reddy's Laboratories Limited25cca459-fdd6-3847-2207-dd4f019781b52018-12-05WarningsExact identifier
application applno (ANDA): 079043
application number: ANDA079043
ndc (product): 55111-557

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 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0049Fexofenadine HCl and Pseudoephedrine HClFexofenadine HCl and Pseudoephedrine HClWalgreens companyANDACurrent
11822-0007Fexofenadine HCl and Pseudoephedrine HClFexofenadine HCl and Pseudoephedrine HClRite Aid CorporationANDACurrent
11822-0007Fexofenadine HCl and Pseudoephedrine HClFexofenadine HCl and Pseudoephedrine HClRite Aid CorporationANDACurrent
21130-557Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCISafeway IncANDACurrent
43598-892Fexofenadine HCl and Pseudoephedrine HClFexofenadine HCl and Pseudoephedrine HClDr.Reddy's Laboratories IncANDACurrent
51316-018Fexofenadine HCl and Pseudoephedrine HClFexofenadine HCl and Pseudoephedrine HClCVS Pharmacy, IncANDACurrent
55111-557Fexofenadine HCl and Pseudoephedrine HCIFexofenadine HCl and Pseudoephedrine HCIDr.Reddy's Laboratories LimitedANDACurrent
55111-572Fexofenadine HCl and Pseudoephedrine HClFexofenadine HCl and Pseudoephedrine HClDr.Reddy's Laboratories LimitedANDACurrent
70000-0607Fexofenadine HCl and Pseudoephedrine HClFexofenadine HCl and Pseudoephedrine HClCardinal HealthANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9212SUPPL2011-06-29