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

NDC Listings For This Application#

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