FDA.report

Application 077170

Type
ANDA
Sponsor
IVAX SUB TEVA PHARMS

Related Records

Application Products

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

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0176Good Sense All Day Allergy DCetirizine HCl, Pseudoephedrine HClL. Perrigo CompanyANDACurrent
0113-2176All Day Allergy-DCetirizine HCl, Pseudoephedrine HClL. Perrigo CompanyANDACurrent
0363-0929Wal Zyr DCetirizine HCl, Pseudoephedrine HClWalgreen CompanyANDACurrent
0363-0929Wal Zyr DCetirizine HCl, Pseudoephedrine HClWalgreen CompanyANDACurrent
0904-5831All day Allergy dCetirizine HCl, Pseudoephedrine HClMajor PharmaceuticalsANDACurrent
11673-555up and up allergy plus congestion relief dCetirizine HCl, Pseudoephedrine HClTarget CorporationANDACurrent
11822-0566allergy and congestion relief dCetirizine HCl, Pseudoephedrine HClRite Aid CorporationANDACurrent
11822-0566allergy and congestion relief dCetirizine HCl, Pseudoephedrine HClRite Aid CorporationANDACurrent
11822-0566allergy and congestion relief dCetirizine HCl, Pseudoephedrine HClRite Aid CorporationANDACurrent
21130-176Signature Care Allergy Relief DCetirizine HCl, Pseudoephedrine HClSafewayANDACurrent
21130-176Signature Care Allergy Relief DCetirizine HCl, Pseudoephedrine HClSafewayANDACurrent
24385-175Good Neighbor Pharmacy All Day Allergy DCetirizine HCl, Pseudoephedrine HClAmerisource BergenANDACurrent
24385-175Good Neighbor Pharmacy All Day Allergy DCetirizine HCl, Pseudoephedrine HClAmerisource BergenANDACurrent
24385-175Good Neighbor Pharmacy All Day Allergy DCetirizine HCl, Pseudoephedrine HClAmerisource BergenANDACurrent
30142-176all day allergy dCetirizine HCl, Pseudoephedrine HClKroger CompanyANDACurrent
36800-176Topcare All Day Allergy DCetirizine HCl, Pseudoephedrine HClTopco Associates LLCANDACurrent
36800-176Topcare All Day Allergy DCetirizine HCl, Pseudoephedrine HClTopco Associates LLCANDACurrent
37012-176Allergy Relief DCetirizine HCl, Pseudoephedrine HClShopko Stores Operating Co., LLCANDACurrent
37012-176Allergy Relief DCetirizine HCl, Pseudoephedrine HClShopko Stores Operating Co., LLCANDACurrent
37205-827Leader Allergy D 12Cetirizine HCl, Pseudoephedrine HClCardinal HealthANDACurrent
37205-827Leader Allergy D 12Cetirizine HCl, Pseudoephedrine HClCardinal HealthANDACurrent
37808-176all day Allergy Relief DCetirizine HCl, Pseudoephedrine HClH E BANDACurrent
37808-785allergy relief dCetirizine HCl, Pseudoephedrine HClH E BANDACurrent
37808-785allergy relief dCetirizine HCl, Pseudoephedrine HClH E BANDACurrent
41163-176Equaline All Day Allergy DCetirizine HCl, Pseudoephedrine HClSupervalu IncANDACurrent
41163-176Equaline All Day Allergy DCetirizine HCl, Pseudoephedrine HClSupervalu IncANDACurrent
41190-176ShopRite Allergy D 12Cetirizine HCl, Pseudoephedrine HClWakefern Food CorporationANDACurrent
41190-176ShopRite Allergy D 12Cetirizine HCl, Pseudoephedrine HClWakefern Food CorporationANDACurrent
41250-29912 hour allergy dCetirizine HCl, Pseudoephedrine HClMeijer Distribution IncANDACurrent
41520-091CareOne Allergy Relief DCetirizine HCl, Pseudoephedrine HClAmerican Sales CompanyANDACurrent
41520-091CareOne Allergy Relief DCetirizine HCl, Pseudoephedrine HClAmerican Sales CompanyANDACurrent
41520-091CareOne Allergy Relief DCetirizine HCl, Pseudoephedrine HClAmerican Sales CompanyANDACurrent
41520-355CareOne All Day Allergy DCetirizine HCl, Pseudoephedrine HClAmerican Sales CompanyANDACurrent
42507-176All Day Allergy DCetirizine HCl, Pseudoephedrine HClHyVee IncANDACurrent
42507-176All Day Allergy DCetirizine HCl, Pseudoephedrine HClHyVee IncANDACurrent
45802-721Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine HCl, Pseudoephedrine HClPerrigo New York IncANDACurrent
45802-721Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine HCl, Pseudoephedrine HClPerrigo New York IncANDACurrent
45802-721Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine HCl, Pseudoephedrine HClPadagis Israel Pharmaceuticals LtdANDACurrent
49348-851Sunmark All Day Allergy DCetirizine HCl, Pseudoephedrine HClMcKessonANDACurrent
49348-851Sunmark All Day Allergy DCetirizine HCl, Pseudoephedrine HClStrategic Sourcing Services LLCANDACurrent
49738-709smart sense allergy relief dCetirizine HCl, Pseudoephedrine HClKmart CorporationANDACurrent
49738-709smart sense allergy relief dCetirizine HCl, Pseudoephedrine HClKmart CorporationANDACurrent
50090-1098Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine HCl, Pseudoephedrine HClA-S Medication SolutionsANDACurrent
50090-1098Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine HCl, Pseudoephedrine HClA-S Medication SolutionsANDACurrent
50090-1098Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine HCl, Pseudoephedrine HClA-S Medication SolutionsANDACurrent
50090-2537Sunmark All Day Allergy DCetirizine HCl, Pseudoephedrine HClA-S Medication SolutionsANDACurrent
50090-2537Sunmark All Day Allergy DCetirizine HCl, Pseudoephedrine HClA-S Medication SolutionsANDACurrent
50090-2537Sunmark All Day Allergy DCetirizine HCl, Pseudoephedrine HClA-S Medication SolutionsANDACurrent
55316-176Healthy Accents Cetirizine-DCetirizine HCl, Pseudoephedrine HClDZA Brands LLCANDACurrent
56062-176Allergy Relief DCetirizine HCl, Pseudoephedrine HClPublix Super Markets IncANDACurrent
59779-176Allergy ReliefCetirizine HCl, Pseudoephedrine HClCVS PharmacyANDACurrent
59779-176Allergy ReliefCetirizine HCl, Pseudoephedrine HClCVS PharmacyANDACurrent
62011-0055health mart allergy complete dCetirizine HCl, Pseudoephedrine HClMcKessonANDACurrent
62011-0055health mart allergy complete dCetirizine HCl, Pseudoephedrine HClStrategic Sourcing Services LLCANDACurrent
63187-955Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine HCl, Pseudoephedrine HClProficient Rx LPANDACurrent
63187-955Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine HCl, Pseudoephedrine HClProficient Rx LPANDACurrent
63981-176Kirkland Signature Aller Tec DCetirizine HCl, Pseudoephedrine HClCostco Wholesale CompanyANDACurrent
68258-8907Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine HCl, Pseudoephedrine HClDispensing Solutions, Inc.ANDACurrent
69256-176harris teeter all day allergy dCetirizine HCl, Pseudoephedrine HClHarris Teeter, LLCANDACurrent
69256-176harris teeter all day allergy dCetirizine HCl, Pseudoephedrine HClHarris Teeter, LLCANDACurrent
70000-0392leader allergy relief dCetirizine Hydrochloride, Pseudoephedrine HydrochlorideCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0392leader allergy relief dCetirizine Hydrochloride, Pseudoephedrine HydrochlorideCardinal HealthANDACurrent

Documents

DocumentSubmission typeDate
43115ORIG2015-11-27
39521ORIG2008-02-28
31202ORIG2008-02-27