Application 078336

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo
003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDETABLET;ORAL5MGNoNo
004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDETABLET;ORAL10MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078336-001CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A078336-002CETIRIZINE HYDROCHLORIDE ALLERGYCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27
A078336-003CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE5MGTABLET / ORAL2007-12-27
A078336-004CETIRIZINE HYDROCHLORIDE HIVESCETIRIZINE HYDROCHLORIDE10MGTABLET / ORAL2007-12-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-09-14 22:38:342026-08A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2784e616aacf4f…
2026-08-18 06:07:402026-07A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-08-18 06:07:402026-07A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-001CETIRIZINE HYDROCHLORIDE ALLERGY5MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-002CETIRIZINE HYDROCHLORIDE ALLERGY10MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-003CETIRIZINE HYDROCHLORIDE HIVES5MGTABLET / ORAL2007-12-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A078336-004CETIRIZINE HYDROCHLORIDE HIVES10MGTABLET / ORAL2007-12-275bbf6a4d5a75…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 3 · 44 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
signature care allergy reliefCETIRIZINE HYDROCHLORIDESafeway24099cbf-61ee-4ec8-a4ec-95a66ceaa0c02025-12-04WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 21130-090
GOODNOW ALLERGY RELIEFCETIRIZINE HYDROCHLORIDEGobrands, Inc86ade508-8841-47d8-addb-418ecd6dc8de2025-11-07WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEVERITYRX, LLC43f40b92-f0e0-8808-e063-6394a90a656b2025-10-30WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CetirizineCETIRIZINE HYDROCHLORIDEA-S Medication Solutions88c3d23e-a0d8-4464-9414-666d74f11f662025-10-28WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
allergy reliefCETIRIZINE HYDROCHLORIDESafewayc5e74b2c-7871-4f28-a77d-0d674b9b8c5e2025-09-23WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Equaline all day allergyCETIRIZINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI491fae66-83b6-4beb-945b-39b9e4e021c52025-09-18WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 41163-458
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEPreferred Pharmaceuticals Inc0827643a-29b8-487a-a158-28976d672d4d2025-09-12WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
CareOne Allergy ReliefCETIRIZINE HYDROCHLORIDEAmerican Sales Company533abfc1-226e-4a68-bfcc-ec046a4d57512025-08-25WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 41520-781
welby allergy reliefCETIRIZINE HYDROCHLORIDEAldi Inccf6b3017-c8b6-4862-aa33-19ed02a43c282025-08-11WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
good neighbor pharmacy all day allergyCETIRIZINE HYDROCHLORIDEAmerisource Bergenc568e388-60ab-47be-b362-7832b83d06ad2025-07-21WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 24385-998
leader all day allergyCETIRIZINE HYDROCHLORIDECardinal Health 110, LLC. dba Leaderce1cef83-e9d1-4cd6-b0e7-b2eb9ce06ddf2025-07-21WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
24 hour allergyCETIRIZINE HYDROCHLORIDEMeijer Distribution Inc2b03c026-3e8a-4283-981f-965bc084c03d2025-07-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 41250-458
kirkland signature aller tec allergyCETIRIZINE HYDROCHLORIDECostco Wholesale Companyd4a688aa-02d4-4af6-9a91-ed31679cfaf82025-06-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEBryant Ranch Prepackae93976d-de9b-43a6-b299-ce1f1ae8d6f82025-05-21WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd91fe3ab8-c155-4482-9f06-f029d3563aad2025-03-06WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
ndc (product): 45802-919
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEAphena Pharma Solutions - Tennessee, LLC25db4ca0-0c25-f3b6-e063-6394a90a88512024-11-01WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Members Mark Allergy ReliefCETIRIZINE HYDROCHLORIDESam's West Inc379756fd-f92d-4773-94fd-2682fcbdfba22024-05-10WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
cetirizine hydrochlorideCETIRIZINE HYDROCHLORIDEPD-Rx Pharmaceuticals, Inc.af7513ae-5107-477c-a7da-0ded9d53a55c2024-03-27WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutions2f562a13-8909-4107-b135-10333707bab32024-01-24WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336
Good Sense all day allergyCETIRIZINE HYDROCHLORIDEA-S Medication Solutionsc1a208c8-2554-4e8e-b506-aeb8e417d4442024-01-24WarningsExact identifier
application applno (ANDA): 078336
application number: ANDA078336

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 2 · 153 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-7002Basic Care All Day AllergyCetirizine HydrochlorideL. Perrigo CompanyANDACurrent
0113-7002Basic Care All Day AllergyCetirizine HydrochlorideL. Perrigo CompanyANDACurrent
0113-9458Good Sense all day allergyCetirizine HydrochlorideL Perrigo CompanyANDACurrent
0113-9458Good Sense all day allergyCetirizine HydrochlorideL Perrigo CompanyANDACurrent
0113-9458Good Sense all day allergyCetirizine HydrochlorideL Perrigo CompanyANDACurrent
0113-9458Good Sense all day allergyCetirizine HydrochlorideL. Perrigo CompanyANDACurrent
0363-0495Wal ZyrCetirizine HydrochlorideWalgreen CompanyANDACurrent
0363-0495Wal ZyrCetirizine HydrochlorideWalgreen CompanyANDACurrent
0363-0495Wal ZyrCetirizine HydrochlorideWalgreen CompanyANDACurrent
0363-4101allergy reliefCetirizine HydrochlorideWalgreen CompanyANDACurrent
0363-4101allergy reliefCetirizine HydrochlorideWalgreen CompanyANDACurrent
0363-4101allergy reliefCetirizine HydrochlorideWalgreen CompanyANDACurrent
0615-8240cetirizine hydrochlorideCetirizine HydrochlorideNCS HealthCare of KY, LLC dba Vangard LabsANDACurrent
0615-8240cetirizine hydrochlorideCetirizine HydrochlorideNCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0904-6717CetirizineCetirizine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6717CetirizineCetirizine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6717CetirizineCetirizine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6717CetirizineCetirizine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6717CetirizineCetirizine HydrochlorideMajor PharmaceuticalsANDACurrent
0904-6717CetirizineCetirizine HydrochlorideMajor PharmaceuticalsANDACurrent
10202-4587 select all day allergyCetirizine Hydrochloride7-ElevenANDACurrent
10202-4587 select all day allergyCetirizine Hydrochloride7-ElevenANDACurrent
11673-502Up and Up Allergy ReliefCetirizine HydrochlorideTarget CorporationANDACurrent
11673-502Up and Up Allergy ReliefCetirizine HydrochlorideTarget CorporationANDACurrent
11673-502Up and Up Allergy ReliefCetirizine HydrochlorideTarget CorporationANDACurrent
11822-0458allergy reliefCetirizine HydrochlorideRite Aid CorporationANDACurrent
11822-0458allergy reliefCetirizine HydrochlorideRite Aid CorporationANDACurrent
11822-0458allergy reliefCetirizine HydrochlorideRite Aid CorporationANDACurrent
11822-1002all day allergyCetirizine HydrochlorideRite Aid CorporationANDACurrent
11822-1002all day allergyCetirizine HydrochlorideRite Aid CorporationANDACurrent
21130-090signature care allergy reliefCetirizine HydrochlorideSafewayANDACurrent
21130-090signature care allergy reliefCetirizine HydrochlorideSafewayANDACurrent
21130-090signature care allergy reliefCetirizine HydrochlorideSafewayANDACurrent
21130-090signature care allergy reliefCetirizine HydrochlorideSafewayANDACurrent
24385-998good neighbor pharmacy all day allergyCetirizine HydrochlorideAmerisource BergenANDACurrent
24385-998good neighbor pharmacy all day allergyCetirizine HydrochlorideAmerisource BergenANDACurrent
30142-458All Day AllergyCetirizine HydrochlorideKroger CompanyANDACurrent
30142-458All Day AllergyCetirizine HydrochlorideKroger CompanyANDACurrent
30142-458All Day AllergyCetirizine HydrochlorideKroger CompanyANDACurrent
36800-458TopCare All Day AllergyCetirizine HydrochlorideTopco Associates LLCANDACurrent
36800-458TopCare All Day AllergyCetirizine HydrochlorideTopco Associates LLCANDACurrent
37012-458Allergy ReliefCetirizine HydrochlorideShopko Stores Operating Co., LLCANDACurrent
37012-458Allergy ReliefCetirizine HydrochlorideShopko Stores Operating Co., LLCANDACurrent
37808-458Rx Act all day allergy reliefCetirizine HydrochlorideH E BANDACurrent
37808-550all day allergy reliefCetirizine HydrochlorideH E BANDACurrent
37808-583allergy reliefCetirizine HydrochlorideH E BANDACurrent
37808-583allergy reliefCetirizine HydrochlorideH E BANDACurrent
37808-583allergy reliefCetirizine HydrochlorideH E BANDACurrent
41163-458Equaline all day allergyCetirizine HydrochlorideSupervalu IncANDACurrent
41163-458Equaline all day allergyCetirizine HydrochlorideSupervalu IncANDACurrent
41163-458Equaline all day allergyCetirizine HydrochlorideSupervalu IncANDACurrent
41163-458Equaline all day allergyCetirizine HydrochlorideSupervalu IncANDACurrent
41190-458ShopRite AllergyCetirizine HydrochlorideWakefern Food CorporationANDACurrent
41190-458ShopRite AllergyCetirizine HydrochlorideWakefern Food CorporationANDACurrent
41250-45824 hour allergyCetirizine HydrochlorideMeijer Distribution IncANDACurrent
41250-45824 hour allergyCetirizine HydrochlorideMeijer Distribution IncANDACurrent
41250-45824 hour allergyCetirizine HydrochlorideMeijer Distribution IncANDACurrent
41250-45824 hour allergyCetirizine HydrochlorideMeijer Distribution IncANDACurrent
41250-721allergy reliefCetirizine HydrochlorideMeijer, Inc.ANDACurrent
41250-721allergy reliefCetirizine HydrochlorideMeijer, Inc.ANDACurrent
41520-781CareOne Allergy ReliefCetirizine HydrochlorideAmerican Sales CompanyANDACurrent
41520-781CareOne Allergy ReliefCetirizine HydrochlorideAmerican Sales CompanyANDACurrent
41520-781CareOne Allergy ReliefCetirizine HydrochlorideAmerican Sales CompanyANDACurrent
45802-919cetirizine hydrochlorideCetirizine HydrochloridePadagis Israel Pharmaceuticals LtdANDACurrent
45802-919cetirizine hydrochlorideCetirizine HydrochloridePerrigo New York IncANDACurrent
45802-919cetirizine hydrochlorideCetirizine HydrochloridePerrigo New York IncANDACurrent
49035-458equate allergy reliefCetirizine HydrochlorideWal-Mart Stores IncANDACurrent
49035-458equate allergy reliefCetirizine HydrochlorideWal-Mart Stores IncANDACurrent
49035-458equate allergy reliefCetirizine HydrochlorideWal-Mart Stores IncANDACurrent
49738-600smart sense allergy reliefCetirizine HydrochlorideKmart CorporationANDACurrent
50090-4344cetirizine hydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-4358cetirizine hydrochlorideCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5510CetirizineCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
50090-5510CetirizineCetirizine HydrochlorideA-S Medication SolutionsANDACurrent
50594-006sound body all day allergyCetirizine HydrochlorideBig Lots Stores, Inc.ANDACurrent
50594-006sound body all day allergyCetirizine HydrochlorideBig Lots Stores, Inc.ANDACurrent
50594-006sound body all day allergyCetirizine HydrochlorideBig Lots Stores, Inc.ANDACurrent
55154-8081CetirizineCetirizine HydrochlorideCardinal Health 107, LLCANDACurrent
55154-8081CetirizineCetirizine HydrochlorideCardinal HealthANDACurrent
55301-076Exchange select all day allergyCetirizine HydrochlorideArmy & Air Force Exchange ServiceANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9145ORIG2008-01-09
18480ORIG2008-01-08