FDA.reportPublic FDA data

Application 090922

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;120MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0989Wal-Zyr DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
0363-0989Wal-Zyr DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
0363-0989Wal-Zyr DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
0363-0989Wal-Zyr DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
49035-982Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideEQUATE (WAL-MART STORES, INC.)ANDACurrent
51660-940Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideOhm Laboratories Inc.ANDACurrent
51660-940Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideOhm Laboratories Inc.ANDACurrent
51660-940Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideOhm Laboratories Inc.ANDACurrent
62756-915Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-915Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-915Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
63868-964Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine HydrochlorideChain Drug Marketing Association, Inc.ANDACurrent
68016-531Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideCHAIN DRUG CONSORTIUM,LLCANDACurrent
69842-994Allergy Relief-DCetirizine hydrochloride and pseudoephedrine hydrochlorideCVS PHARMACYANDACurrent
70000-0163Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideCardinal HealthANDACurrent
70677-0146all day allergy-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideStrategic Sourcing ServicesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22719ORIG2015-11-17