FDA.report

Application 210719

Type
ANDA
Sponsor
PERRIGO R AND D

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
0113-0147good sense all day allergy dCetirizine hydrochloride, Pseudoephedrine hydrochlorideL. Perrigo CompanyANDACurrent
0363-1147WAL ZYR Dcetirizine hydrochloride, pseudoephedrine hydrochlorideWalgreen CompanyANDACurrent
0363-4923allergy relief D12Cetirizine hydrochloride, Pseudoephedrine hydrochlorideWalgreen CompanyANDACurrent
0536-1279Rugby Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine hydrochloride, Pseudoephedrine hydrochlorideRugby LaboratoriesANDACurrent
0536-1279Rugby Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine hydrochloride, Pseudoephedrine hydrochlorideRugby LaboratoriesANDACurrent
11822-0147allergy and congestion relief dCetirizine hydrochloride, Pseudoephedrine hydrochlorideRite Aid CorporationANDACurrent
11822-0147allergy and congestion relief dCetirizine hydrochloride, Pseudoephedrine hydrochlorideRite Aid CorporationANDACurrent
21130-644signature care allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochlorideSafewayANDACurrent
30142-450all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochlorideKroger CompanyANDACurrent
30142-450all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochlorideKroger CompanyANDACurrent
36800-744topcare all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochlorideTopco Associates LLCANDACurrent
36800-744topcare all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochlorideTopco Associates LLCANDACurrent
36800-744topcare all day allergy dcetirizine hydrochloride, pseudoephedrine hydrochlorideTopco Associates LLCANDACurrent
37808-651allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochlorideH E BANDACurrent
41250-72812 hour allergy dcetirizine hydrochloride, pseudoephedrine hydrochlorideMeijer Distribution IncANDACurrent
41250-72812 hour allergy dcetirizine hydrochloride, pseudoephedrine hydrochlorideMeijer Distribution IncANDACurrent
45802-147Cetirizine hydrochloride and Pseudoephedrine hydrochlorideCetirizine hydrochloride, Pseudoephedrine hydrochloridePerrigo New York IncANDACurrent
45802-147Cetirizine hydrochloride and Pseudoephedrine hydrochlorideCetirizine hydrochloride, Pseudoephedrine hydrochloridePerrigo New York IncANDACurrent
45802-147Cetirizine hydrochloride and Pseudoephedrine hydrochlorideCetirizine hydrochloride, Pseudoephedrine hydrochloridePadagis Israel Pharmaceuticals LtdANDACurrent
46122-626good neighbor pharmacy all day allergy dCetirizine hydrochloride, Pseudoephedrine hydrochlorideAmerisource BergenANDACurrent
46122-626good neighbor pharmacy all day allergy dCetirizine hydrochloride, Pseudoephedrine hydrochlorideAmerisource BergenANDACurrent
56062-147allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochloridePublix Super Markets IncANDACurrent
62011-0411health mart allergy complete dCetirizine hydrochloride, Pseudoephedrine hydrochlorideStrategic Sourcing Services LLCANDACurrent
62011-0411health mart allergy complete dCetirizine hydrochloride, Pseudoephedrine hydrochlorideStrategic Sourcing Services LLCANDACurrent
63981-147kirkland signature aller tec dcetirizine hydrochloride, pseudoephedrine hydrochlorideCostco Wholesale CompanyANDACurrent
63981-147kirkland signature aller tec dcetirizine hydrochloride, pseudoephedrine hydrochlorideCostco Wholesale CompanyANDACurrent
69842-415allergy relief dcetirizine hydrochloride, pseudoephedrine hydrochlorideCVS PharmacyANDACurrent
70000-0042Leader Allergy Relief DCetirizine hydrochloride, Pseudoephedrine hydrochlorideCardinal HealthANDACurrent
70000-0042Leader Allergy Relief DCetirizine hydrochloride, Pseudoephedrine hydrochlorideCardinal Health 110, LLC. dba LeaderANDACurrent
70000-0042Leader Allergy Relief DCetirizine hydrochloride, Pseudoephedrine hydrochlorideCardinal HealthANDACurrent
70677-0077sunmark all day allergy dCetirizine hydrochloride, Pseudoephedrine hydrochlorideStrategic Sourcing Services LLCANDACurrent
70677-0077sunmark all day allergy dCetirizine hydrochloride, Pseudoephedrine hydrochlorideStrategic Sourcing Services LLCANDACurrent
79903-126equate allergy relief d nasal decongestantCetirizine hydrochloride, Pseudoephedrine hydrochlorideWALMART INC.ANDACurrent