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 11 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CHILDRENS LORATADINELORATADINETARGET CORPORATIONc5e87776-71e3-4c46-a8e7-30f47f437bef2024-06-28WarningsName fallback
generic name: LORATADINE
Dye-Free Childrens LoratadineLORATADINEUP & UP85ea5c40-d02f-4c91-8eb2-4b16877e1eab2024-06-28WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEWALGREEN CO.c016aad8-df83-99b0-e053-2a95a90a49cf2024-06-24WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
Alavert AllergyLORATADINEFoundation Consumer Healthcare1704474a-9b99-de45-e063-6294a90ac59b2024-06-24WarningsName fallback
generic name: LORATADINE
Loratadine ODTLORATADINEWALGREEN CO.7556b959-3ff2-4489-ae06-67ef398c623c2024-06-18WarningsName fallback
generic name: LORATADINE
All Day Allergy ReliefLORATADINEQUALITY CHOICE (Chain Drug Marketing Association)a282d209-1015-4570-b9df-7cc0a3753e372024-06-17WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINECardinal Healthc96dd1c9-85a0-0792-e053-2a95a90a22642024-06-14WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
childrens allergy reliefLORATADINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDbc789b82-56ca-4248-b60a-252d9695636a2024-06-12WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINENuCare Pharmaceuticals,Inc.6d0c0948-9288-9bb8-e053-2a91aa0abf3a2024-06-10WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
Allergy ReliefLORATADINEQUALITY CHOICE (Chain Drug Marketing Association)c5acd9d7-2f26-41c5-b369-2122251583ec2024-05-17WarningsName fallback
generic name: LORATADINE
All Day Allergy ReliefLORATADINEQUALITY CHOICE (Chain Drug Marketing Association)d47a5f1b-fb27-4618-a26e-a5eeabcd87f22024-05-16WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEKROGER COMPANY087ee83f-71aa-3d47-e063-6394a90aed4d2024-05-08WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LORATADINELORATADINETenshi Kaizen Pvt Ltd9c168fbb-6668-4a9d-9c7e-d3441e60eb952024-05-07WarningsName fallback
brand name: LORATADINE
generic name: LORATADINE
CHILDRENS LORATADINE ODTLORATADINEWALGREEN CO.cd597728-35fb-4e43-85ea-84af802e19832024-05-04WarningsName fallback
generic name: LORATADINE
Alavert AllergyLORATADINEFoundation Consumer Healthcare15c3f848-fef6-433b-e063-6394a90abd2b2024-05-01WarningsName fallback
generic name: LORATADINE
Loratadine antihistamineLORATADINEAphena Pharma Solutions - Tennessee, LLCa2c92766-df4e-4414-9c42-e18bcf9db6b42024-04-09WarningsName fallback
generic name: LORATADINE
Loratadine Allergy ReliefLORATADINEBryant Ranch Prepack40914eeb-3a85-4691-9fb8-2df72ba1f7092024-04-05WarningsName fallback
generic name: LORATADINE
Loratadine Allergy ReliefLORATADINEBryant Ranch Prepack94642b79-f91a-429f-87f4-dad326d4f3ed2024-04-03WarningsName fallback
generic name: LORATADINE
good sense allergy reliefLORATADINEA-S Medication Solutionsc288d849-59c9-4883-aac4-bae54acee8ac2024-03-27WarningsName fallback
generic name: LORATADINE
DYE-FREE CHILDRENS LORATADINELORATADINEOhm Laboratories Inc.10b0e325-335b-05b6-e063-6394a90a8c2f2024-03-15WarningsName fallback
generic name: LORATADINE

Reported adverse events (FAERS/openFDA)#

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