FDA.reportPublic FDA data

Application 076471

Type
ANDA
Sponsor
APOTEX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LORATADINELORATADINETABLET;ORAL10MGNoNo

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
A076471-001LORATADINELORATADINE10MGTABLET / ORAL2006-02-14

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 UTC2022-10A076471-001LORATADINE10MGTABLET / ORAL2006-02-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A076471-001LORATADINE10MGTABLET / ORAL2006-02-14e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A076471-001LORATADINE10MGTABLET / ORAL2006-02-14cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A076471-001LORATADINE10MGTABLET / ORAL2006-02-14a50c72e98297…

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Non-Drowsy Allergy ReliefLORATADINE TABLETLil' Drug Store Products, Inc.031fc3e5-b5eb-447c-e063-6294a90a13b52023-08-17WarningsExact identifier
application applno (ANDA): 076471
application number: ANDA076471
Allergy ReliefLORATADINEAllegiant Health0991388a-2eb8-4913-9efc-adf411eddf3a2018-11-08WarningsExact identifier
application applno (ANDA): 076471
application number: ANDA076471
ndc (product): 69168-309
AllergyLORATADINESelder, S.A. de C.V.afdb0117-dd2d-4ab1-a2f4-2a88b6bf52512016-12-22WarningsExact identifier
application applno (ANDA): 076471
application number: ANDA076471
ndc (product): 63654-309

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 · 37 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0536-1092LORATADINELoratadineRugby LaboratoriesANDACurrent
0536-1092LORATADINELoratadineRugby LaboratoriesANDACurrent
0904-5793LORATADINELoratadineMajor PharmaceuticalsANDACurrent
0904-5793LORATADINELoratadineMajor PharmaceuticalsANDACurrent
10544-455LoratadineLoratadineBlenheim Pharmacal, Inc.ANDACurrent
24286-1568Allergy ReliefLoratadineDLC LABORATORIES, INCANDACurrent
50090-0838LoratadineLoratadineA-S Medication SolutionsANDACurrent
50090-0838LoratadineLoratadineA-S Medication SolutionsANDACurrent
50268-488LoratadineLoratadineAvPAKANDACurrent
53117-309Allergy ReliefLoratadineFirst Aid DirectANDACurrent
53117-407Allergy ReliefLoratadineFirst Aid DirectANDACurrent
57896-788Allergy reliefLoratadineGeri-Care Pharmaceutical CorpANDACurrent
57896-788Allergy reliefLoratadineGeri-Care Pharmaceutical CorpANDACurrent
60505-0147LoratadineLoratadineApotex Corp.ANDACurrent
60505-0147LoratadineLoratadineApotex Corp.ANDACurrent
60505-0147LoratadineLoratadineApotex Corp.ANDACurrent
60505-0147LoratadineLoratadineApotex Corp.ANDACurrent
60505-4649LORATADINELoratadineApotex Corp.ANDACurrent
60505-4649LORATADINELoratadineApotex Corp.ANDACurrent
63654-309AllergyLoratadineSelder, S.A. de C.V.ANDACurrent
63654-309AllergyLoratadineSelder, S.A. de C.V.ANDACurrent
68071-4318Allergy reliefLoratadineNuCare Pharmaceuticals,Inc.ANDACurrent
68071-4318Allergy reliefLoratadineNuCare Pharmaceuticals,Inc.ANDACurrent
68788-7085LORATADINELoratadinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7085LORATADINELoratadinePreferred Pharmaceuticals Inc.ANDACurrent
68788-7085LORATADINELoratadinePreferred Pharmaceuticals Inc.ANDACurrent
68998-309Allergy ReliefLoratadineMarc Glassman, Inc.ANDACurrent
68998-309Allergy ReliefLoratadineMarc Glassman, Inc.ANDACurrent
68998-309Allergy ReliefLoratadineMarc Glassman, Inc.ANDACurrent
68998-407Allergy ReliefLoratadineMarc Glassman, Inc.ANDACurrent
69168-309Allergy ReliefLoratadineAllegiant HealthANDACurrent
69168-309Allergy ReliefLoratadineAllegiant HealthANDACurrent
69168-309Allergy ReliefLoratadineAllegiant HealthANDACurrent
70000-0317LORATADINELoratadineCardinal HealthANDACurrent
70000-0317LORATADINELoratadineCardinal HealthANDACurrent
70518-1262LORATADINELoratadineREMEDYREPACK INC.ANDACurrent
70518-1262LORATADINELoratadineREMEDYREPACK INC.ANDACurrent