FDA.reportPublic FDA data

Application 207235

Type
ANDA
Sponsor
APOTEX

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDECAPSULE;ORAL10MGNoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-1036good sense all day allergyCetirizine hydrochlorideL. Perrigo CompanyANDACurrent
0113-7036BASIC CARE ALL DAY ALLERGYCetirizine hydrochlorideL. Perrigo CompanyANDACurrent
0363-0741Wal-ZyrCetirizine HClWalgreensANDACurrent
0363-0741Wal-ZyrCetirizine HClWalgreensANDACurrent
0363-0741Wal-ZyrCetirizine HClWalgreensANDACurrent
0363-1040CetirizineCetirizineWalgreensANDACurrent
0363-1040CetirizineCetirizineWalgreensANDACurrent
0363-1040CetirizineCetirizineWalgreensANDACurrent
11673-219CetirizineCetirizineTARGET CORPORATIONANDACurrent
11673-219CetirizineCetirizineTARGET CORPORATIONANDACurrent
11822-0457allergy reliefCetirizine hydrochlorideRite Aid CorporationANDACurrent
21130-741Allergy ReliefCetirizine HClSafeway, Inc.ANDACurrent
21130-741Allergy ReliefCetirizine HClSafeway, Inc.ANDACurrent
21130-741Allergy ReliefCetirizine HClSafeway, Inc.ANDACurrent
30142-741All Day Allergy ReliefCetirizine HClThe Kroger Co.ANDACurrent
30142-741All Day Allergy ReliefCetirizine HClThe Kroger Co.ANDACurrent
30142-741All Day Allergy ReliefCetirizine HClThe Kroger Co.ANDACurrent
33992-0741Allergy ReliefCetirizine HClASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
33992-0741Allergy ReliefCetirizine HClASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
33992-0741Allergy ReliefCetirizine HClASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
33992-0741Allergy ReliefCetirizine HClASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
33992-0741Allergy ReliefCetirizine HClASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
33992-0741Allergy ReliefCetirizine HClASSURED / DOLLAR TREE (Greenbrier International, Inc.)ANDACurrent
36800-180top care all day allergycetirizine hydrochlorideTopco Associates LLCANDACurrent
36800-741All Day AllergyCetirizine HClTOP CARE (Topco Associates LLC)ANDACurrent
36800-741All Day AllergyCetirizine HClTOP CARE (Topco Associates LLC)ANDACurrent
36800-741All Day AllergyCetirizine HClTOP CARE (Topco Associates LLC)ANDACurrent
37808-741Allergy ReliefCetirizine HClH E BANDACurrent
37808-741Allergy ReliefCetirizine HClH E BANDACurrent
37808-741Allergy ReliefCetirizine HClH E BANDACurrent
37808-741Allergy ReliefCetirizine HClH E BANDACurrent
41250-61824 hour allergyCetirizine hydrochlorideMeijer Distribution IncANDACurrent
41250-741Allergy ReliefCetirizine HClMEIJER, INC.ANDACurrent
41250-741Allergy ReliefCetirizine HClMEIJER, INC.ANDACurrent
41250-741Allergy ReliefCetirizine HClMEIJER, INC.ANDACurrent
41250-741Allergy ReliefCetirizine HClMEIJER, INC.ANDACurrent
41520-715CareOne Allergy Reliefcetirizine hydrochlorideAmerican Sales CompanyANDACurrent
41520-741Allergy ReliefCetirizine HClCare One (American Sales Company)ANDACurrent
41520-741Allergy ReliefCetirizine HClCare One (American Sales Company)ANDACurrent
41520-741Allergy ReliefCetirizine HClCare One (American Sales Company)ANDACurrent
49035-841Allergy ReliefCetirizine HClEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
49035-841Allergy ReliefCetirizine HClEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)ANDACurrent
49035-841Allergy ReliefCetirizine HClEQUATE (Wal-Mart Stores, Inc.)ANDACurrent
55315-741Allergy ReliefCetirizine HClFreds IncANDACurrent
55315-741Allergy ReliefCetirizine HClFreds IncANDACurrent
55315-741Allergy ReliefCetirizine HClFreds IncANDACurrent
55315-741Allergy ReliefCetirizine HClFreds IncANDACurrent
55910-710dg health all day allergyCetirizine hydrochlorideDolgencorp, LLCANDACurrent
56062-741Allergy ReliefCetirizine HClPublix Supermarkets, Inc.ANDACurrent
56062-741Allergy ReliefCetirizine HClPublix Supermarkets, Inc.ANDACurrent
56062-741Allergy ReliefCetirizine HClPublix Supermarkets, Inc.ANDACurrent
59726-041All Day Allergy ReliefCetirizine HClP & L Development, LLCANDACurrent
59726-041All Day Allergy ReliefCetirizine HClP & L Development, LLCANDACurrent
59726-741All Day Allergy ReliefCetirizine HClP & L Development, LLCANDACurrent
59726-741All Day Allergy ReliefCetirizine HClP & L Development, LLCANDACurrent
60505-4322CetirizineCetirizineApotex Corp.ANDACurrent
60505-4322CetirizineCetirizineApotex Corp.ANDACurrent
60505-4668CetirizineCetirizineApotex Corp.ANDACurrent
60505-4668CetirizineCetirizineApotex Corp.ANDACurrent
60505-4668CetirizineCetirizineApotex Corp.ANDACurrent
60505-4706CetirizineCetirizineApotex Corp.ANDACurrent
60505-4706CetirizineCetirizineApotex Corp.ANDACurrent
60505-4706CetirizineCetirizineApotex Corp.ANDACurrent
63868-432All Day Allergy ReliefCetirizine HClQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-432All Day Allergy ReliefCetirizine HClQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
63868-432All Day Allergy ReliefCetirizine HClQUALITY CHOICE (Chain Drug Marketing Association)ANDACurrent
69230-303Allergy ReliefCetirizine HClCamber Consumer CareANDACurrent
69230-303Allergy ReliefCetirizine HClCamber Consumer CareANDACurrent
69230-303Allergy ReliefCetirizine HClCamber Consumer CareANDACurrent
69230-303Allergy ReliefCetirizine HClCamber Consumer CareANDACurrent
69842-741Allergy ReliefCetirizine HClCVS PharmacyANDACurrent
69842-741Allergy ReliefCetirizine HClCVS PharmacyANDACurrent
69842-741Allergy ReliefCetirizine HClCVS PharmacyANDACurrent
72288-007basic care all day allergyCetirizine hydrochlorideAmazon.com Services LLCANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45224ORIG2016-08-12