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 13 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
All Day Allergy ReliefLORATADINEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)7eac9202-bd4c-4550-a257-2b8195a0dbcd2023-11-29WarningsName fallback
generic name: LORATADINE
Allergy ReliefLORATADINEAMERIFOODS TRADING COMPANYf6ce5292-f698-dd2f-e053-6394a90ad74a2023-11-02WarningsName fallback
generic name: LORATADINE
foster and thrive childrens allergy reliefLORATADINEStrategic Sourcing Services LLC5ac59de8-46ad-4731-8f98-167fb5f8b0892023-10-30WarningsName fallback
generic name: LORATADINE
All Day Allergy ReliefLORATADINEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)9ea4fde8-e091-412d-9de1-dd66a2ab73e42023-10-26WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINE ORALBetter Living Brands LLCf7dc7a3d-6709-d7e7-e053-6394a90acde82023-09-26WarningsName fallback
brand name: Loratadine
Loratadine ODTLORATADINEBetter Living Brands, LLCfad93257-bfcf-5e04-e053-6394a90a10a62023-09-25WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINECamber Consumer Care Incd57da4bd-af37-414a-a50c-e80d2bb283142023-09-08WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
Equaline Childrens Allergy ReliefLORATADINEUnited Natural Foods, Inc. dba UNFI25329c7d-76e7-47b3-914e-ac367bbb750b2023-08-17WarningsName fallback
generic name: LORATADINE
Loratadine ODTLORATADINEAmerisource Bergend2524455-b6c4-442b-b139-666a555c52982023-07-10WarningsName fallback
generic name: LORATADINE
LORATADINELORATADINEDr. Reddy's Laboratories Inc.d707733d-1ee9-92d3-f5b2-3567b9c217c22023-06-25WarningsName fallback
brand name: LORATADINE
generic name: LORATADINE
LORATADINELORATADINEDr. Reddy's Laboratories Inc.bb6af6a4-aec0-ddf5-57b7-063504ca8e1e2023-06-25WarningsName fallback
brand name: LORATADINE
generic name: LORATADINE
topcare childrens allergy reliefLORATADINETopco Associates LLC4f7555ea-6286-4ff6-b125-d12660ae4bdf2023-06-20WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEPLD Acquisitions LLC DBA Avma Pharma Solutions2edb53f8-7661-4e54-bb50-e03078bae3bf2023-05-04WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
childrens allergy reliefLORATADINERite Aid Corporationf8ddeb7e-94b1-4dce-815f-b6b8c71e88fd2023-04-13WarningsName fallback
generic name: LORATADINE
Claritin, BSX Non-Drowsy, 24 HourLORATADINELil' Drug Store Products, Incf85b0527-107c-4a4a-aad7-61d2f52bad632023-03-17WarningsName fallback
generic name: LORATADINE
Handy Solutions 24 Hour AllergyLORATADINENavajo Manufacturing Company Inc.67263031-9095-48f2-8b34-e589b28a74162023-03-15WarningsName fallback
generic name: LORATADINE
ClaritinLORATADINENavajo Manufacturing Company60a5dc14-3f74-8414-e053-2991aa0ad34a2023-03-01WarningsName fallback
generic name: LORATADINE
ClaritinLORATADINENavajo Manufacturing Company Inc.219ab9c4-d0c4-4256-ab64-66d0260886bd2023-03-01WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEWalgreens Company8229ca40-31cf-3dbd-078d-364f5674cb212023-02-27WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINEDr. Reddy's Laboratories Inc.9357186a-9452-e139-01d8-6b8c6f6a2c6b2023-02-24WarningsName fallback
brand name: Loratadine
generic name: LORATADINE

Reported adverse events (FAERS/openFDA)#

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