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 15 of 18 · 342 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Loratadine ODTLORATADINEAurohealth LLCa6e04fe7-23d3-47d7-9f18-5c4298fbc28b2022-06-20WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEBluePoint Laboratoriesadc506ed-7a7a-facc-e053-2a95a90ae1472022-06-20WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINEAurohealth LLCc6bfb54a-04d8-41c1-9fa9-5d4bae0a66d12022-06-18WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
Dye-Free Childrens LoratadineLORATADINERITE AID322d9a03-a908-4858-b25e-6eba2411fa032022-06-02WarningsName fallback
generic name: LORATADINE
Allergy ReliefLORATADINEAAA PHARMACEUTICAL, INC.9c8535e3-6a60-4640-b37e-a2260936d9af2022-04-21WarningsName fallback
generic name: LORATADINE
signature care allergy reliefLORATADINESafeway0a4b8eef-762e-42cc-84ee-0018a9a3be582022-04-04WarningsName fallback
generic name: LORATADINE
Loratadine antihistamineLORATADINEProficient Rx LPe9b87f79-ebed-4677-8e50-00cb4282ee562022-04-01WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINERising Pharmaceuticals, Incd28128a3-af54-440e-9bd4-0fccf393d18a2022-03-10WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
topcare childrens allergyLORATADINETopco Associates LLC6e175fae-05dd-45c2-b9ab-7d49369a3c052022-02-28WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINESAFEWAY INC.1092b8af-25f2-4c25-b3bc-5ffb14e960242021-12-21WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
LoratadineLORATADINECVS Pharmacye63f082c-ff50-43ed-ad2c-598b352413e82021-12-21WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
Topcare Allergy ReliefLORATADINETopco Associates LLC32f4e1d1-c830-4752-8251-bcc233bf03f62021-11-29WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINEMARKSANS PHARMA LIMITEDc30907f9-1761-41e5-bd4e-2613e756e1c62021-11-15WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
careone allergy reliefLORATADINEAmerican Sales Companyfdacfd88-eb85-4a33-9863-c6ff484fea4e2021-11-15WarningsName fallback
generic name: LORATADINE
Childrens Allergy ReliefLORATADINEH E B704ee04d-6bdd-4d0a-ba24-2a9fd79a90fb2021-08-24WarningsName fallback
generic name: LORATADINE
Basic Care Childrens Allergy ReliefLORATADINEAmazon.com Services LLCe2c83874-aa95-477a-9cfd-cecfd776ba0e2021-08-12WarningsName fallback
generic name: LORATADINE
good sense allergy reliefLORATADINEL. Perrigo Companya8f97128-3af8-493d-8e66-a1e07f5941312021-07-14WarningsName fallback
generic name: LORATADINE
Allergy ReliefLORATADINEDISCOUNT DRUG MARTc29bf35f-1f19-c3c9-e053-2995a90ac1b62021-07-12WarningsName fallback
generic name: LORATADINE
LoratadineLORATADINECardinal Health, 110 dba LEADERdb9d2182-6bf1-424a-a144-f2694c47989f2021-06-23WarningsName fallback
brand name: Loratadine
generic name: LORATADINE
dg health allergy reliefLORATADINEDolgencorp, LLCc18c40ae-19c8-4699-842a-43a5c4c236d52021-06-22WarningsName fallback
generic name: LORATADINE

Reported adverse events (FAERS/openFDA)#

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