FDA.reportPublic FDA data

Application 090922

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;120MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28

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 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090922-001CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE5MG;120MGTABLET, EXTENDED RELEASE / ORAL2012-09-28a50c72e98297…

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 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDERITE AID1bf7c028-1648-4211-8847-84cce833a0f12025-01-02WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEOhm Laboratories Inc.c24f3760-70e0-410f-bf80-6d0cadcd61b92024-12-16WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
ndc (product): 51660-940
Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDESun Pharmaceutical Industries, Inc.796c4b81-145b-4050-a851-dec81ff970062024-11-27WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
ndc (product): 62756-915
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDESTRATEGIC SOURCING SERVICES LLC97997887-9cba-48f8-abcd-fdb86829459c2024-10-03WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
Wal-Zyr DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEWalgreen Company778ba62e-6cce-4d0f-b6d9-48b35ef40da72024-01-25WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
ndc (product): 0363-0989
Allergy Relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECVS PHARMACY54a158e3-f545-4a01-bf8d-e72a286d734c2024-01-12WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
ndc (product): 69842-994
Allergy relief-DCETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDECHAIN DRUG CONSORTIUM,LLC0f5de86d-1c87-4664-83f6-4c17f78f7d352018-11-30WarningsExact identifier
application applno (ANDA): 090922
application number: ANDA090922
ndc (product): 68016-531

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 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0363-0989Wal-Zyr DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
0363-0989Wal-Zyr DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
0363-0989Wal-Zyr DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
0363-0989Wal-Zyr DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideWalgreen CompanyANDACurrent
49035-982Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideEQUATE (WAL-MART STORES, INC.)ANDACurrent
51660-940Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideOhm Laboratories Inc.ANDACurrent
51660-940Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideOhm Laboratories Inc.ANDACurrent
51660-940Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideOhm Laboratories Inc.ANDACurrent
62756-915Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-915Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
62756-915Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine HydrochlorideSun Pharmaceutical Industries, Inc.ANDACurrent
63868-964Cetirizine Hydrochloride and Pseudoephedrine HydrochlorideCetirizine Hydrochloride and Pseudoephedrine HydrochlorideChain Drug Marketing Association, Inc.ANDACurrent
68016-531Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideCHAIN DRUG CONSORTIUM,LLCANDACurrent
69842-994Allergy Relief-DCetirizine hydrochloride and pseudoephedrine hydrochlorideCVS PHARMACYANDACurrent
70000-0163Allergy relief-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideCardinal HealthANDACurrent
70677-0146all day allergy-DCetirizine Hydrochloride and Pseudoephedrine HydrochlorideStrategic Sourcing ServicesANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
22719ORIG2015-11-17