FDA.reportPublic FDA data

Application 022429

Type
NDA
Sponsor
BIONPHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDECAPSULE;ORAL5MGYesNo
002CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDECAPSULE;ORAL10MGYesYes
003CETIRIZINE HYDROCHLORIDE HIVES RELIEFCETIRIZINE HYDROCHLORIDECAPSULE;ORAL5MGYesNo
004CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDECAPSULE;ORAL10MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0211Wal-ZyrCetirizine HClWalgreensNDACurrent
0363-021124 Hour AllergyCetirizine HClWalgreensNDACurrent
0363-0921Allergy ReliefCetirizine HClWalgreensNDACurrent
0363-0921Wal-ZyrCetirizine HClWalgreensNDACurrent
0363-0921Wal-ZyrCetirizine HClWalgreensNDACurrent
0363-0921Wal-ZyrCetirizine HClWalgreensNDACurrent
0363-121924 Hour AllergyCetirizine HClWalgreensNDACurrent
0363-121924 HOUR ALLERGYCetirizine HClWalgreensNDACurrent
0363-121924 HOUR ALLERGYCetirizine HClWalgreensNDACurrent
0363-121924 Hour AllergyCetirizine HClWalgreensNDACurrent
11673-211Allergy ReliefCetirizine HClTARGET CorporationNDACurrent
11673-211Allergy ReliefCetirizine HClTARGET CorporationNDACurrent
11673-242Cetirizine HClCetirizine HClTARGET CorporationNDACurrent
11673-242Cetirizine HClCetirizine HClTARGET CorporationNDACurrent
30142-211All Day AllergyCetirizine HClThe Kroger Co.NDACurrent
30142-211All Day AllergyCetirizine HClThe Kroger Co.NDACurrent
30142-211All Day AllergyCetirizine HClThe Kroger Co.NDACurrent
30142-995Cetirizine HClCetirizine HClKROGER COMPANYNDACurrent
30142-995Cetirizine HClCetirizine HClKROGER COMPANYNDACurrent
30142-995Cetirizine HClCetirizine HClKROGER COMPANYNDACurrent
36800-211All Day AllergyCetirizine HClTOP CARE (Topco Associates LLC)NDACurrent
36800-211All Day AllergyCetirizine HClTOP CARE (Topco Associates LLC)NDACurrent
37205-819All Day AllergyCetirizine HClCardinal Health (Leader) 37205NDACurrent
37808-211All Day AllergyCetirizine HClH E BNDACurrent
37808-211All Day AllergyCetirizine HClH E BNDACurrent
37808-211All Day AllergyCetirizine HClH E BNDACurrent
41163-219all day allergyCetirizine HClSUPERVALU INCNDACurrent
41520-211All Day AllergyCetirizine HClCare One (American Sales Company)NDACurrent
41520-211All Day AllergyCetirizine HClCare One (American Sales Company)NDACurrent
42507-211All Day AllergyCetirizine HClHy-VeeNDACurrent
42507-211All Day AllergyCetirizine HClHy-VeeNDACurrent
42507-211All Day AllergyCetirizine HClHy-VeeNDACurrent
46122-613Cetirizine HClCetirizine HClAMERISOURCE BERGENNDACurrent
46122-613Cetirizine HClCetirizine HClAMERISOURCE BERGENNDACurrent
49035-711Allergy ReliefCetirizine HClEQUATE (Wal-Mart Stores, Inc.)NDACurrent
49035-711Allergy ReliefCetirizine HClEQUATE (Wal-Mart Stores, Inc.)NDACurrent
49035-711Allergy ReliefCetirizine HClEQUATE (Wal-Mart Stores, Inc.)NDACurrent
49035-911Allergy ReliefCetirizine HClEQUATE (Wal-Mart Stores, Inc.)NDACurrent
49035-911Allergy ReliefCetirizine HClEQUATE (Wal-Mart Stores, Inc.)NDACurrent
49035-911Allergy ReliefCetirizine HClEQUATE (Wal-Mart Stores, Inc.)NDACurrent
49738-211Cetirizine HClCetirizine HydrochlorideSMART SENSE (Kmart)NDACurrent
49738-211Cetirizine HClCetirizine HydrochlorideSMART SENSE (Kmart)NDACurrent
49738-211Cetirizine HClCetirizine HydrochlorideSMART SENSE (Kmart)NDACurrent
50580-779ZYRTECCetirizine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-779ZYRTECCetirizine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
50580-779ZYRTECCetirizine HydrochlorideJohnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionNDACurrent
53943-219Allergy ReliefCetirizine HClDISCOUNT DRUG MART, INC.NDACurrent
53943-219Allergy ReliefCetirizine HClDISCOUNT DRUG MART, INC.NDACurrent
55312-211Allergy ReliefCetirizine HClWestern Family Foods, Inc.NDACurrent
55315-211All Day AllergyCetirizine HClFreds IncNDACurrent
55315-211All Day AllergyCetirizine HClFreds IncNDACurrent
56062-211Allergy ReliefCetirizine HClPublix Supermarkets, Inc.NDACurrent
56062-211Allergy ReliefCetirizine HClPublix Supermarkets, Inc.NDACurrent
56062-211Allergy ReliefCetirizine HClPublix Supermarkets, Inc.NDACurrent
59726-211All Day AllergyCetirizine HClP & L Development, LLCNDACurrent
59726-212All Day Allergy ReliefCetirizine HClP & L Development, LLCNDACurrent
59726-212All Day Allergy ReliefCetirizine HClP & L Development, LLCNDACurrent
59726-212All Day Allergy ReliefCetirizine HClP & L Development, LLCNDACurrent
59779-415Indoor/Outdoor ALLERGY RELIEF SoftgelsCetirizine HydrochlorideCVS PharmacyNDACurrent
63868-107All Day Allergy ReliefCetirizine HClQUALITY CHOICE (Chain Drug Marketing Association)NDACurrent
63868-139All Day AllergyCetirizine HClQUALITY CHOICE (Chain Drug Marketing Association)NDACurrent
63868-139All Day AllergyCetirizine HClQUALITY CHOICE (Chain Drug Marketing Association)NDACurrent
63868-139All Day AllergyCetirizine HClQUALITY CHOICE (Chain Drug Marketing Association)NDACurrent
63868-433All Day Allergy ReliefCetirizine HClCHAIN DRUG MARKETING ASSOCIATION INC.NDACurrent
63868-433All Day Allergy ReliefCetirizine HClCHAIN DRUG MARKETING ASSOCIATION INC.NDACurrent
63868-433All Day Allergy ReliefCetirizine HClCHAIN DRUG MARKETING ASSOCIATION INC.NDACurrent
63940-211Allergy ReliefCetirizine HClHarmon StoresNDACurrent
63940-211Allergy ReliefCetirizine HClHarmon StoresNDACurrent
68016-279All Day AllergyCetirizine HydrochlorideChain Drug Consortium, LLCNDACurrent
69452-265Cetirizine HClCetirizine HClBionpharma Inc.NDACurrent
69452-265Cetirizine HClCetirizine HClBionpharma Inc.NDACurrent
69452-265Cetirizine HClCetirizine HClBionpharma Inc.NDACurrent
69452-265Cetirizine HClCetirizine HClBionpharma Inc.NDACurrent
69842-911ALLERGY RELIEFCetirizine HydrochlorideCVS PharmacyNDACurrent
69842-911ALLERGY RELIEFCetirizine HydrochlorideCVS PharmacyNDACurrent
69842-911ALLERGY RELIEFCetirizine HydrochlorideCVS PharmacyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
84917SUPPL 2026-02-05
84893SUPPL 2026-02-03
65538SUPPL2020-12-09
62568SUPPL2020-04-14
62567SUPPL2020-04-14
17582SUPPL2014-01-14
29725SUPPL2013-02-07
7385SUPPL2010-04-08
42521ORIG2009-12-16