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 9 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
topcare allergy reliefLORATADINETopco Associates LLC5cc2e469-9080-4beb-804d-187fc335ccdc2025-02-10WarningsName fallback
generic name: LORATADINE
Loratadine antihistamineLORATADINENuCare Pharmaceuticals,Inc.fc63689e-e449-ca8f-e053-6394a90a54a22025-02-05WarningsName fallback
generic name: LORATADINE
Allergy reliefLORATADINEBryant Ranch Prepacke87aa69c-9ec6-482d-8e28-32542f6b91662025-02-04WarningsName fallback
generic name: LORATADINE
ALLERGY RELIEFLORATADINETARGET CORPORATION7cb1364b-0852-3444-e053-2991aa0a36292025-02-01WarningsName fallback
generic name: LORATADINE
Allergy reliefLORATADINEA-S Medication Solutions210fa77a-e33e-48c4-8228-b1cf3ccb7fa42025-01-30WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEGobrands, Inc1d182bd6-ad72-4352-b983-407a48c317f02025-01-25WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
Loratadine ODTLORATADINEWal-Mart Stores, Inc.7679ee14-08aa-459c-9107-1a71443799622025-01-23WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEBryant Ranch Prepack7f97595b-9df7-4834-82f0-5e4ce329c1182025-01-21WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINE ORALAurohealth LLC0b86a9fe-db7e-470a-a8fa-d7d4373116ba2025-01-20WarningsName fallback
brand name: Loratadine
Loratadine antihistamineLORATADINENuCare Pharmaceuticals,Inc.54b37bcc-a8b0-0c17-e054-00144ff8d46c2025-01-09WarningsName fallback
generic name: LORATADINE
LORATADINELORATADINEAMZ789 LLCdb71197e-d633-644d-e053-2a95a90a261d2025-01-08WarningsName fallback
brand name: LORATADINE
generic name: LORATADINE
LORATADINELORATADINECVS PHARMACY, INC4e74e322-7f6e-467c-96c0-9b531ddb429b2024-12-31WarningsName fallback
brand name: LORATADINE
generic name: LORATADINE
LoratadineLORATADINEAdvanced Rx Pharmacy of Tennessee, LLC01cb43cf-57a9-f189-e063-6294a90afd882024-12-31WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
CHILDRENS LORATADINELORATADINESAFEWAYdad93ac1-ae0b-4918-8c62-92107e79a4b22024-12-29WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEWALGREEN COMPANY645c26ab-08ab-4a69-ae7d-7802d8ec59222024-12-29WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
Wal-itinLORATADINEWalgreens176fe4f5-f72d-4fc2-bd9a-20626c9ab6342024-12-27WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEPremier Valuedc22862e-fe91-4900-8c2b-1ca45aeedbf02024-12-27WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
CHILDRENS LORATADINELORATADINETARGET CORPORATIONc02ad905-2363-4092-a90e-3be789112cb12024-12-27WarningsName fallback
generic name: LORATADINE
Childrens AllergyLORATADINETARGET CORPORATION9507c223-ea75-477e-b765-f5d0bcba5ff92024-12-27WarningsName fallback
generic name: LORATADINE
AllervarxLORATADINEInnovus Pharmaceuticals, Inc.ec4d1e77-6995-4228-8e63-a9ab6232dace2024-12-27WarningsName fallback
generic name: LORATADINE

Reported adverse events (FAERS/openFDA)#

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