Home Applications 021952 Application 021952
Type NDA
Sponsor BAYER HEALTHCARE LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 CLARITIN LORATADINE CAPSULE;ORAL 10MG Yes Yes
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-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021952-001 CLARITIN LORATADINE 10MG CAPSULE / ORAL RLD, RS 2008-06-16
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.
Product history page 1 of 2 · 43 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 f41ea6bd6efb…
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 9 of 17 · 339 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Allergy relief LORATADINE Bryant Ranch Prepack e87aa69c-9ec6-482d-8e28-32542f6b9166 2025-02-04 Warnings Name fallback generic name: LORATADINE ALLERGY RELIEF LORATADINE TARGET CORPORATION 7cb1364b-0852-3444-e053-2991aa0a3629 2025-02-01 Warnings Name fallback generic name: LORATADINE Allergy relief LORATADINE A-S Medication Solutions 210fa77a-e33e-48c4-8228-b1cf3ccb7fa4 2025-01-30 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Gobrands, Inc 1d182bd6-ad72-4352-b983-407a48c317f0 2025-01-25 Warnings Name fallback generic name: LORATADINE Loratadine ODT LORATADINE Wal-Mart Stores, Inc. 7679ee14-08aa-459c-9107-1a7144379962 2025-01-23 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Bryant Ranch Prepack 7f97595b-9df7-4834-82f0-5e4ce329c118 2025-01-21 Warnings Name fallback generic name: LORATADINE Loratadine antihistamine LORATADINE NuCare Pharmaceuticals,Inc. 54b37bcc-a8b0-0c17-e054-00144ff8d46c 2025-01-09 Warnings Name fallback generic name: LORATADINE LORATADINE LORATADINE AMZ789 LLC db71197e-d633-644d-e053-2a95a90a261d 2025-01-08 Warnings Name fallback generic name: LORATADINE LORATADINE LORATADINE CVS PHARMACY, INC 4e74e322-7f6e-467c-96c0-9b531ddb429b 2024-12-31 Warnings Name fallback generic name: LORATADINE Claritin LORATADINE TABLET Lil' Drug Store Products, Inc. f0e77162-c601-1a0f-e053-2a95a90ab714 2024-12-31 Warnings Name fallback brand name: Claritin Loratadine LORATADINE Advanced Rx Pharmacy of Tennessee, LLC 01cb43cf-57a9-f189-e063-6294a90afd88 2024-12-31 Warnings Name fallback generic name: LORATADINE CHILDRENS LORATADINE LORATADINE SAFEWAY dad93ac1-ae0b-4918-8c62-92107e79a4b2 2024-12-29 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE WALGREEN COMPANY 645c26ab-08ab-4a69-ae7d-7802d8ec5922 2024-12-29 Warnings Name fallback generic name: LORATADINE Wal-itin LORATADINE Walgreens 176fe4f5-f72d-4fc2-bd9a-20626c9ab634 2024-12-27 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Premier Value dc22862e-fe91-4900-8c2b-1ca45aeedbf0 2024-12-27 Warnings Name fallback generic name: LORATADINE CHILDRENS LORATADINE LORATADINE TARGET CORPORATION c02ad905-2363-4092-a90e-3be789112cb1 2024-12-27 Warnings Name fallback generic name: LORATADINE Childrens Allergy LORATADINE TARGET CORPORATION 9507c223-ea75-477e-b765-f5d0bcba5ff9 2024-12-27 Warnings Name fallback generic name: LORATADINE Allervarx LORATADINE Innovus Pharmaceuticals, Inc. ec4d1e77-6995-4228-8e63-a9ab6232dace 2024-12-27 Warnings Name fallback generic name: LORATADINE Allervarx LORATADINE Innovus Pharmaceuticals, Inc. 885e81ae-5ea3-4d14-8666-8c2698767014 2024-12-27 Warnings Name fallback generic name: LORATADINE LORATADINE LORATADINE Bionpharma Inc. 4fa705fb-859e-4046-b153-a8338c50a97d 2024-12-23 Warnings Name fallback generic name: LORATADINE
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 10 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 11523-7200 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7200 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7200 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7200 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7200 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7333 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7333 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7333 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7333 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7333 Claritin Loratadine Bayer HealthCare LLC. NDA Current