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 6 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Loratadine OralLORATADINEMajor Pharmaceuticals3f0f0131-b516-4ff3-8049-3d3766324b662025-11-13WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEAurobindo Pharma Limited4f4ffb72-f4e8-4617-8bc5-61e6de488a2d2025-11-12WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINEA-S Medication Solutionsc84c2696-0d55-48a2-9d32-ca6c9bc57aa22025-11-11WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINEA-S Medication Solutions26c19e5b-7288-41a2-baaf-b4af196301402025-11-10WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINEA-S Medication Solutions0eade963-be64-4718-a370-7e78efb91fc42025-11-06WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINEA-S Medication Solutions6f82e0ab-2c01-4afb-8d0f-b0c06819d1b02025-11-06WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINEA-S Medication Solutions4cee60b6-b32b-47d0-aa00-a7ea1a7ed3cf2025-11-06WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
Allergy ReliefLORATADINEWinCo Foods, LLC3dea627d-4b0c-e077-e063-6394a90a15a02025-11-03WarningsName fallback
generic name: LORATADINE
All Day Allergy ReliefLORATADINEFamily Dollar (FAMILY WELLNESS)6b8d786e-2ee3-487f-bf7b-7dc738ea2fc92025-10-29WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINECabinet Health P.B.C.8b090fa2-9535-456c-b14d-187a2873cdf72025-10-27WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
CVS LoratadineLORATADINECVS Pharmacy3d716988-da63-59e6-e063-6394a90a5b4b2025-10-22WarningsName fallback
generic name: LORATADINE
equate loratadineLORATADINEWALMART INC.882dc99b-22d2-4f3e-8613-9ac8d9c5d9102025-10-14WarningsName fallback
generic name: LORATADINE
Good Sense childrens allergy reliefLORATADINENuCare Pharmaceuticals,Inc.40d25cdf-b63f-d5c9-e063-6394a90af5092025-10-10WarningsName fallback
generic name: LORATADINE
SinuLiefLORATADINERoseWell Pharmaceuticals LLC32619143-a782-3497-e063-6394a90aaaec2025-10-06WarningsName fallback
generic name: LORATADINE
ALLERGY RELIEFLORATADINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED31cb3c06-7e15-4000-b169-50b66c14b01b2025-10-06WarningsName fallback
generic name: LORATADINE
Loratadine antihistamineLORATADINEPadagis Israel Pharmaceuticals Ltdc72d8a30-520e-4d25-8f02-0c891e070a1a2025-09-12WarningsName fallback
generic name: LORATADINE
Allergy reliefLORATADINEPreferred Pharmaceuticals Inc.836f566c-0296-408a-ad2a-6a77e18552182025-08-29WarningsName fallback
generic name: LORATADINE
Wal-itinLORATADINEWalgreens6afa8056-1b7a-48a4-960c-92927169977e2025-08-28WarningsName fallback
generic name: LORATADINE
Childrens Loratadine Sugar FreeLORATADINEH E Bd710b760-794e-490b-a413-c7b2ee5149b92025-08-14WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEGranules India Limited9bae1ba3-c0da-23a2-e053-2a95a90a58ed2025-08-01WarningsName fallback
brand name: Loratadine
generic name: LORATADINE

Reported adverse events (FAERS/openFDA)#

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