FDA.reportPublic FDA data

Application 211983

Type
ANDA
Sponsor
PERRIGO R AND D

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDETABLET;ORAL5MGNoNo

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
A211983-001LEVOCETIRIZINE DIHYDROCHLORIDELEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28

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 UTC2022-10A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211983-001LEVOCETIRIZINE DIHYDROCHLORIDE5MGTABLET / ORAL2019-03-28a50c72e98297…

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 RELIEFLEVOCETIRIZINE DIHYDROCHLORIDEAmazon.com Services LLC9ba39415-34af-49ca-b5cb-464e755179172026-08-12WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
good sense levocetirizineLEVOCETIRIZINE DIHYDROCHLORIDEL. Perrigo Company0b482364-a00a-4b95-975a-f403a3ae4d2e2026-07-13WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
ndc (product): 0113-0241
allergy reliefLEVOCETIRIZINE DIHYDROCHLORIDERite Aid Corporationc6f826a4-cb8d-4a9f-99cc-5041f65801ca2025-10-09WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
ndc (product): 11822-0241
Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEMeijer Distribution Incca6d0ba0-96af-41e9-a3e9-0c7783db30112025-05-20WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
ndc (product): 41250-488
Topcare All Day AllergyLEVOCETIRIZINE DIHYDROCHLORIDETopco Associates LLC393616df-52f1-4e77-b69c-8239ca193d5b2022-02-21WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
ndc (product): 36800-241
DG Health Allergy ReliefLEVOCETIRIZINE DIHYDROCHLORIDEDolgencorp, LLC470fee97-daab-4967-9c0e-77bacfb2ccd82021-06-24WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
ndc (product): 55910-241
basic care allergy reliefLEVOCETIRIZINE DIHYDROCHLORIDEAmazon.com Services LLCfe965a15-7789-4ea5-b33e-2d3513409e1a2020-11-02WarningsExact identifier
application applno (ANDA): 211983
application number: ANDA211983
ndc (product): 72288-241

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 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0113-0241good sense levocetirizinelevocetirizine dihydrochlorideL. Perrigo CompanyANDACurrent
0363-2241levocetirizinelevocetirizine dihydrochlorideWalgreen CompanyANDACurrent
0363-3901allergy relieflevocetirizine dihydrochlorideWalgreen CompanyANDACurrent
11822-0241allergy relieflevocetirizine dihydrochlorideRite Aid CorporationANDACurrent
11822-0241allergy relieflevocetirizine dihydrochlorideRite Aid CorporationANDACurrent
36800-241Topcare All Day Allergylevocetirizine dihydrochlorideTopco Associates LLCANDACurrent
36800-241Topcare All Day Allergylevocetirizine dihydrochlorideTopco Associates LLCANDACurrent
36800-241Topcare All Day Allergylevocetirizine dihydrochlorideTopco Associates LLCANDACurrent
41250-488Allergy Relieflevocetirizine dihydrochlorideMeijer Distribution IncANDACurrent
55910-241DG Health Allergy Relieflevocetirizine dihydrochlorideDolgencorp, LLCANDACurrent
72288-241basic care allergy relieflevocetirizine dihydrochlorideAmazon.com Services LLCANDACurrent