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 16 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
welby all day allergy reliefLORATADINEAldi, Incefe2fa11-8115-4d33-bb32-8e2509839ef42021-06-22WarningsName fallback
generic name: LORATADINE
leader childrens allergy reliefLORATADINECardinal Health 110, LLC. dba Leader20b438e1-f461-48fa-b007-4c02ecb91b682021-06-17WarningsName fallback
generic name: LORATADINE
Allergy ReliefLORATADINEHARRIS TEETERb8f67f52-906e-c7a8-e053-2995a90a5cbd2021-04-29WarningsName fallback
generic name: LORATADINE
Childrens AllergyLORATADINEWal-Mart Stores Inc9fb3a3a8-8812-4238-b596-291b79085db92021-04-15WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEKROGER COMPANYf5fbfb52-197c-437c-8977-23bd7f2ac7bd2021-04-08WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
Allergy ReliefLORATADINEOhm Laboratories Inc.de3a7725-5d1b-4195-a9f8-43f92888997c2021-04-06WarningsName fallback
generic name: LORATADINE
good sense allergy reliefLORATADINEL. Perrigo Company3ef968b8-6732-4c80-b385-f471ed4078172021-03-15WarningsName fallback
generic name: LORATADINE
DYE-FREE CHILDRENS LORATADINELORATADINEPUBLIX SUPER MARKETS, INC28a0c2b7-f793-43ac-90bc-c155ad141eaf2021-01-21WarningsName fallback
generic name: LORATADINE
DYE-FREE CHILDRENS LORATADINELORATADINESAFEWAY7440046f-bf2f-438f-a320-3425d593d1a62021-01-21WarningsName fallback
generic name: LORATADINE
DYE-FREE CHILDRENS LORATADINELORATADINERITE AIDdce7f475-baa9-4f19-ac49-fb1303786ace2021-01-12WarningsName fallback
generic name: LORATADINE
DYE-FREE CHILDRENS LORATADINELORATADINEUP & UP9660f7e6-3a29-4a6d-ba57-92088f624aa42020-11-19WarningsName fallback
generic name: LORATADINE
Allergy ReliefLORATADINEMarc Glassman, Inc.717ccb47-e13c-4464-b6e6-bea8f24d46632020-09-28WarningsName fallback
generic name: LORATADINE
Basic Care Allergy ReliefLORATADINEAmazon.com Services LLCc22c9880-ed0e-48a7-a30e-41f0aed5a2122020-09-03WarningsName fallback
generic name: LORATADINE
Basic Care Allergy ReliefLORATADINEAmazon.com Services LLC2a834b33-5759-4e54-9adc-379310656dee2020-08-19WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEAurohealth LLC196da80c-3dbb-40c7-ac93-8a57d6acb1c32020-08-13WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
careone childrens allergy reliefLORATADINEAmerican Sales Company06d1c443-ec23-4aa1-a7f3-f2b7ffcc25882020-08-10WarningsName fallback
generic name: LORATADINE
Good Neighbor Pharmacy Childrens LoratadineLORATADINEAmerisourceBergen3ffc656a-90f9-4921-9c4f-840023b984332020-06-24WarningsName fallback
generic name: LORATADINE
Allergy ReliefLORATADINEAllegiant Healthf0db3a13-43e6-4243-9a3a-7808ddd005e12020-06-16WarningsName fallback
generic name: LORATADINE
dg health childrens allergy reliefLORATADINEDolgencorp, LLC302fc570-bec9-43cb-8965-139576102cdd2020-06-10WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEAphena Pharma Solutions - Tennessee, LLC8ffe2faf-3253-4121-a069-6f46e319c6f02020-05-13WarningsName fallback
brand name: Loratadine
generic name: LORATADINE

Reported adverse events (FAERS/openFDA)#

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