Home Applications 078336 Application 078336
Type ANDA
Sponsor PERRIGO R AND D Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE TABLET;ORAL 5MG No No 002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE TABLET;ORAL 10MG No No 003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE TABLET;ORAL 5MG No No 004 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 44 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 5MG TABLET / ORAL 2007-12-27 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES CETIRIZINE HYDROCHLORIDE 10MG TABLET / ORAL 2007-12-27
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 5 of 5 · 176 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2022-10-28 04:53 UTC 2022-10 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 f41ea6bd6efb…2022-10-28 04:53 UTC 2022-10 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 e64feba35796…2022-09-29 23:25 UTC 2022-09 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 e64feba35796…2022-09-29 23:25 UTC 2022-09 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 e64feba35796…2022-09-29 23:25 UTC 2022-09 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 cb3db0bc1861…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078336-001 CETIRIZINE HYDROCHLORIDE ALLERGY 5MG TABLET / ORAL 2007-12-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078336-002 CETIRIZINE HYDROCHLORIDE ALLERGY 10MG TABLET / ORAL 2007-12-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078336-003 CETIRIZINE HYDROCHLORIDE HIVES 5MG TABLET / ORAL 2007-12-27 a50c72e98297…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A078336-004 CETIRIZINE HYDROCHLORIDE HIVES 10MG TABLET / ORAL 2007-12-27 a50c72e98297…
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 1 of 3 · 43 matching rows.
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 NDC Name Nonproprietary name Labeler Marketing category Status 0113-7002 Basic Care All Day Allergy Cetirizine Hydrochloride L. Perrigo Company ANDA Current 0113-7002 Basic Care All Day Allergy Cetirizine Hydrochloride L. Perrigo Company ANDA Current 0113-9458 Good Sense all day allergy Cetirizine Hydrochloride L Perrigo Company ANDA Current 0113-9458 Good Sense all day allergy Cetirizine Hydrochloride L Perrigo Company ANDA Current 0113-9458 Good Sense all day allergy Cetirizine Hydrochloride L Perrigo Company ANDA Current 0113-9458 Good Sense all day allergy Cetirizine Hydrochloride L. Perrigo Company ANDA Current 0363-0495 Wal Zyr Cetirizine Hydrochloride Walgreen Company ANDA Current 0363-0495 Wal Zyr Cetirizine Hydrochloride Walgreen Company ANDA Current 0363-0495 Wal Zyr Cetirizine Hydrochloride Walgreen Company ANDA Current 0363-4101 allergy relief Cetirizine Hydrochloride Walgreen Company ANDA Current 0363-4101 allergy relief Cetirizine Hydrochloride Walgreen Company ANDA Current 0363-4101 allergy relief Cetirizine Hydrochloride Walgreen Company ANDA Current 0615-8240 cetirizine hydrochloride Cetirizine Hydrochloride NCS HealthCare of KY, LLC dba Vangard Labs ANDA Current 0615-8240 cetirizine hydrochloride Cetirizine Hydrochloride NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0904-6717 Cetirizine Cetirizine Hydrochloride Major Pharmaceuticals ANDA Current 0904-6717 Cetirizine Cetirizine Hydrochloride Major Pharmaceuticals ANDA Current 0904-6717 Cetirizine Cetirizine Hydrochloride Major Pharmaceuticals ANDA Current 0904-6717 Cetirizine Cetirizine Hydrochloride Major Pharmaceuticals ANDA Current 0904-6717 Cetirizine Cetirizine Hydrochloride Major Pharmaceuticals ANDA Current 0904-6717 Cetirizine Cetirizine Hydrochloride Major Pharmaceuticals ANDA Current 10202-458 7 select all day allergy Cetirizine Hydrochloride 7-Eleven ANDA Current 10202-458 7 select all day allergy Cetirizine Hydrochloride 7-Eleven ANDA Current 11673-502 Up and Up Allergy Relief Cetirizine Hydrochloride Target Corporation ANDA Current 11673-502 Up and Up Allergy Relief Cetirizine Hydrochloride Target Corporation ANDA Current 11673-502 Up and Up Allergy Relief Cetirizine Hydrochloride Target Corporation ANDA Current 11822-0458 allergy relief Cetirizine Hydrochloride Rite Aid Corporation ANDA Current 11822-0458 allergy relief Cetirizine Hydrochloride Rite Aid Corporation ANDA Current 11822-0458 allergy relief Cetirizine Hydrochloride Rite Aid Corporation ANDA Current 11822-1002 all day allergy Cetirizine Hydrochloride Rite Aid Corporation ANDA Current 11822-1002 all day allergy Cetirizine Hydrochloride Rite Aid Corporation ANDA Current 21130-090 signature care allergy relief Cetirizine Hydrochloride Safeway ANDA Current 21130-090 signature care allergy relief Cetirizine Hydrochloride Safeway ANDA Current 21130-090 signature care allergy relief Cetirizine Hydrochloride Safeway ANDA Current 21130-090 signature care allergy relief Cetirizine Hydrochloride Safeway ANDA Current 24385-998 good neighbor pharmacy all day allergy Cetirizine Hydrochloride Amerisource Bergen ANDA Current 24385-998 good neighbor pharmacy all day allergy Cetirizine Hydrochloride Amerisource Bergen ANDA Current 30142-458 All Day Allergy Cetirizine Hydrochloride Kroger Company ANDA Current 30142-458 All Day Allergy Cetirizine Hydrochloride Kroger Company ANDA Current 30142-458 All Day Allergy Cetirizine Hydrochloride Kroger Company ANDA Current 36800-458 TopCare All Day Allergy Cetirizine Hydrochloride Topco Associates LLC ANDA Current 36800-458 TopCare All Day Allergy Cetirizine Hydrochloride Topco Associates LLC ANDA Current 37012-458 Allergy Relief Cetirizine Hydrochloride Shopko Stores Operating Co., LLC ANDA Current 37012-458 Allergy Relief Cetirizine Hydrochloride Shopko Stores Operating Co., LLC ANDA Current 37808-458 Rx Act all day allergy relief Cetirizine Hydrochloride H E B ANDA Current 37808-550 all day allergy relief Cetirizine Hydrochloride H E B ANDA Current 37808-583 allergy relief Cetirizine Hydrochloride H E B ANDA Current 37808-583 allergy relief Cetirizine Hydrochloride H E B ANDA Current 37808-583 allergy relief Cetirizine Hydrochloride H E B ANDA Current 41163-458 Equaline all day allergy Cetirizine Hydrochloride Supervalu Inc ANDA Current 41163-458 Equaline all day allergy Cetirizine Hydrochloride Supervalu Inc ANDA Current 41163-458 Equaline all day allergy Cetirizine Hydrochloride Supervalu Inc ANDA Current 41163-458 Equaline all day allergy Cetirizine Hydrochloride Supervalu Inc ANDA Current 41190-458 ShopRite Allergy Cetirizine Hydrochloride Wakefern Food Corporation ANDA Current 41190-458 ShopRite Allergy Cetirizine Hydrochloride Wakefern Food Corporation ANDA Current 41250-458 24 hour allergy Cetirizine Hydrochloride Meijer Distribution Inc ANDA Current 41250-458 24 hour allergy Cetirizine Hydrochloride Meijer Distribution Inc ANDA Current 41250-458 24 hour allergy Cetirizine Hydrochloride Meijer Distribution Inc ANDA Current 41250-458 24 hour allergy Cetirizine Hydrochloride Meijer Distribution Inc ANDA Current 41250-721 allergy relief Cetirizine Hydrochloride Meijer, Inc. ANDA Current 41250-721 allergy relief Cetirizine Hydrochloride Meijer, Inc. ANDA Current 41520-781 CareOne Allergy Relief Cetirizine Hydrochloride American Sales Company ANDA Current 41520-781 CareOne Allergy Relief Cetirizine Hydrochloride American Sales Company ANDA Current 41520-781 CareOne Allergy Relief Cetirizine Hydrochloride American Sales Company ANDA Current 45802-919 cetirizine hydrochloride Cetirizine Hydrochloride Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-919 cetirizine hydrochloride Cetirizine Hydrochloride Perrigo New York Inc ANDA Current 45802-919 cetirizine hydrochloride Cetirizine Hydrochloride Perrigo New York Inc ANDA Current 49035-458 equate allergy relief Cetirizine Hydrochloride Wal-Mart Stores Inc ANDA Current 49035-458 equate allergy relief Cetirizine Hydrochloride Wal-Mart Stores Inc ANDA Current 49035-458 equate allergy relief Cetirizine Hydrochloride Wal-Mart Stores Inc ANDA Current 49738-600 smart sense allergy relief Cetirizine Hydrochloride Kmart Corporation ANDA Current 50090-4344 cetirizine hydrochloride Cetirizine Hydrochloride A-S Medication Solutions ANDA Current 50090-4358 cetirizine hydrochloride Cetirizine Hydrochloride A-S Medication Solutions ANDA Current 50090-5510 Cetirizine Cetirizine Hydrochloride A-S Medication Solutions ANDA Current 50090-5510 Cetirizine Cetirizine Hydrochloride A-S Medication Solutions ANDA Current 50594-006 sound body all day allergy Cetirizine Hydrochloride Big Lots Stores, Inc. ANDA Current 50594-006 sound body all day allergy Cetirizine Hydrochloride Big Lots Stores, Inc. ANDA Current 50594-006 sound body all day allergy Cetirizine Hydrochloride Big Lots Stores, Inc. ANDA Current 55154-8081 Cetirizine Cetirizine Hydrochloride Cardinal Health 107, LLC ANDA Current 55154-8081 Cetirizine Cetirizine Hydrochloride Cardinal Health ANDA Current 55301-076 Exchange select all day allergy Cetirizine Hydrochloride Army & Air Force Exchange Service ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 9145 ORIG 2008-01-09 18480 ORIG 2008-01-08