FDA.reportPublic FDA data

Application 215127

Type
ANDA
Sponsor
CATALENT PHARMA

Application Products#

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

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

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
A215127-001LORATADINELORATADINE10MGCAPSULE / ORAL2025-02-28

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A215127-001LORATADINE10MGCAPSULE / ORAL2025-02-2884e616aacf4f…
2026-08-18 06:07:402026-07A215127-001LORATADINE10MGCAPSULE / ORAL2025-02-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A215127-001LORATADINE10MGCAPSULE / ORAL2025-02-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215127-001LORATADINE10MGCAPSULE / ORAL2025-02-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A215127-001LORATADINE10MGCAPSULE / ORAL2025-02-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A215127-001LORATADINE10MGCAPSULE / ORAL2025-02-28fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215127-001LORATADINE10MGCAPSULE / ORAL2025-02-28a50c72e98297…

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 7 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Loratadine Sugar FreeLORATADINESTRATEGIC SOURCING SERVICES LLC809456dc-1d1c-42a7-b17f-e43dacde927f2025-07-30WarningsName fallback
generic name: LORATADINE
Allergy reliefLORATADINEGeri-Care Pharmaceutical Corpb66f171a-7b95-b27a-e053-2a95a90a60092025-07-28WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEMylan Institutional Inc.1fc9ddd1-393d-4fe2-a9e0-d192df7331db2025-07-22WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINESTRATEGIC SOURCING SERVICES LLC6ba7fc5d-81c4-482c-8b38-4a6587853a9f2025-07-21WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
childrens allergyLORATADINEPublix Super Markets Incfa429380-019e-4ccd-8444-d5d931c4cc652025-07-15WarningsName fallback
generic name: LORATADINE
Nuvicare-Allergy Relief Loratadine Tablets, 10 mgLORATADINENUVICARE LLC023a46f0-8d1c-4f62-953d-3e6458a54f6e2025-07-01WarningsName fallback
generic name: LORATADINE
Gencare-Allergy Relief Loratadine Tablets, 10 mgLORATADINEPioneer Life Sciences, LLC647dc957-4aee-48f6-bb77-e82d3b380e802025-06-30WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINELannett Company, Inc.069c4e75-1f9f-4ab5-9570-3d93d12c2a232025-06-19WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINEBryant Ranch Prepackbaad51cd-daa0-4920-a6d5-2faaaaea79562025-06-18WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINEBryant Ranch Prepack0d74af21-3ef7-418b-a2ef-78737b0af2882025-06-13WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINEBryant Ranch Prepacka5d54183-06a9-4ae1-93b9-e9a2e03ad42b2025-06-13WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
365 Whole Foods Market LoratadineLORATADINEWhole Foods Market, Inc.bba4e7c8-db8e-4522-915c-48ee809e3bce2025-06-11WarningsName fallback
generic name: LORATADINE
Loratadine Allergy ReliefLORATADINEAsclemed USA, Inc.332bda00-1350-2d33-e063-6394a90a8bd72025-05-21WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINE ORALBluePoint Laboratoriesab820f80-b5fc-7896-e053-2995a90a4b1c2025-05-15WarningsName fallback
brand name: Loratadine
Children Claritin AllergyLORATADINEBayer HealthCare LLC.170061e9-e529-4ff0-e054-00144ff8d46c2025-05-15WarningsName fallback
generic name: LORATADINE
basic care childrens allergy reliefLORATADINEAmazon.com Services LLC90f40330-46a6-44cf-9b09-6f791c9b210b2025-05-12WarningsName fallback
generic name: LORATADINE
non drowsy allergy reliefLORATADINEMeijer Distribution Inc4762c96e-d562-4f74-a275-8cba597987f92025-05-08WarningsName fallback
generic name: LORATADINE
Equaline Childrens Allergy ReliefLORATADINEUnited Natural Foods, Inc. dba UNFI11e889d8-833c-4043-a1af-7ffaf3fda61d2025-05-07WarningsName fallback
generic name: LORATADINE
childrens allergy reliefLORATADINEMeijer Distribution Incb27f0bd0-4e61-4498-b5b7-54ae31f637f32025-05-07WarningsName fallback
generic name: LORATADINE
dg health childrens allergyLORATADINEDolgencorp, LLC14acf572-e1f0-40f5-82cf-357cb2f3a0512025-05-07WarningsName fallback
generic name: LORATADINE

Reported adverse events (FAERS/openFDA)#

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