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 12 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dye-Free Childrens LoratadineLORATADINEOhm Laboratories Inc.9e9b2e1c-f565-42ef-9ec4-43bcebc549b72024-03-15WarningsName fallback
generic name: LORATADINE
Dye-Free Childrens LoratadineLORATADINECVS PHARMACY, INC0b78fed4-69eb-f66f-e063-6294a90a3b892024-03-15WarningsName fallback
generic name: LORATADINE
CHILDRENS LORATADINELORATADINESAFEWAY0e0fbbf7-a42e-e101-e063-6294a90a69772024-03-15WarningsName fallback
generic name: LORATADINE
Wal-itinLORATADINEWALGREENS CO.fb9608d9-b401-40d9-aff3-2bc0dc6e92d82024-03-15WarningsName fallback
generic name: LORATADINE
DYE-FREE CHILDRENS LORATADINELORATADINEPUBLIX SUPER MARKETS, INC0b29afdc-3b0f-3958-e063-6394a90a233a2024-03-15WarningsName fallback
generic name: LORATADINE
members mark allergy reliefLORATADINESam's West Inc95c2b45a-d0e5-467c-aad4-7bbb6c9a52042024-03-11WarningsName fallback
generic name: LORATADINE
good sense allergy reliefLORATADINEA-S Medication Solutions5fda4906-4133-4293-8b39-4ddcf8d398012024-02-04WarningsName fallback
generic name: LORATADINE
kirkland signature allerclearLORATADINECostco Wholesale Company2074d52e-8c0a-4e69-bfb1-864ffc07e25f2024-01-17WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEWal-Mart Stores, Incf62c48ab-8dd3-4ed1-a123-d478efe8e8392024-01-11WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
DYE-FREE CHILDRENS LORATADINELORATADINEWAL-MART STORES, INC01d6de60-58b0-453f-a0be-95146ce29ea32024-01-11WarningsName fallback
generic name: LORATADINE
Childrens LoratadineLORATADINEOhm Laboratories Inc.c088c998-d823-4bd0-9382-b567221f85a72024-01-11WarningsName fallback
generic name: LORATADINE
LORATADINE ALLERGY RELIEF 10mgLORATADINEYYBA CORPdcb63e1b-d499-2e84-e053-2995a90af5c72024-01-03WarningsName fallback
generic name: LORATADINE
ALLERGY RELIEF 10mgLORATADINEYYBA CORP6103cf98-40b1-4d27-8eb7-6f6a069497302024-01-03WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINETenshi Kaizen Pvt Ltdc20b91e0-ef92-6f2f-e053-2a95a90a2a362024-01-02WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LORATADINELORATADINECVS PHARMACY, INC7ed2aec0-4da7-4edc-9998-b96c67c827382024-01-02WarningsName fallback
brand name: LORATADINE
generic name: LORATADINE
LORATADINELORATADINEStrides Pharma Inc16ab6610-ac99-4714-848d-9377c6bca4592024-01-02WarningsName fallback
brand name: LORATADINE
generic name: LORATADINE
LORATADINELORATADINEStrides Pharma Inca54cdbe9-32ec-45ca-948f-9cefbb8e3cbf2024-01-02WarningsName fallback
brand name: LORATADINE
generic name: LORATADINE
LORATADINELORATADINETenshi Kaizen Pvt Ltdc20b916d-7dd0-1a56-e053-2995a90a3c1b2024-01-02WarningsName fallback
brand name: LORATADINE
generic name: LORATADINE
LoratadineLORATADINEA-S Medication Solutions0f6fe391-8709-40f0-8f52-e3357e6ea4f92023-12-09WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
Loratadine Allergy ReliefLORATADINEOHM LABORATORIES INC.c35f2cc1-f76d-4824-b0a5-747bca0c3b852023-12-08WarningsName fallback
generic name: LORATADINE

Reported adverse events (FAERS/openFDA)#

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