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 14 of 17 · 339 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Indoor Outdoor Allergy Relief LORATADINE Walgreens 19fb573f-29a1-4166-becb-0698cfbb682c 2022-11-30 Warnings Name fallback generic name: LORATADINE WAL-ITIN LORATADINE WALGREENS 9e155aae-4735-4aab-bda9-c21ea29529a4 2022-11-11 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Chain Drug Consortium, LLC 21199958-ac67-4f72-8a8c-4d7d31fa9da4 2022-11-04 Warnings Name fallback generic name: LORATADINE Loratadine ODT LORATADINE Chain Drug Consortium, LLC 7674009d-492d-4005-a652-f12b91428c0d 2022-11-04 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE McLane Company, Inc. f988f9fb-463d-4aaa-b83d-54a3b114e570 2022-11-04 Warnings Name fallback generic name: LORATADINE Loratadine ODT LORATADINE DISCOUNT DRUG MART b4a11eb4-cff8-4280-9dc9-757d51100354 2022-11-04 Warnings Name fallback generic name: LORATADINE Loratadine ODT LORATADINE Ahold U.S.A., Inc, 092aec8d-57d5-4487-8e1a-b4b586bee7cf 2022-11-04 Warnings Name fallback generic name: LORATADINE Loratadine ODT LORATADINE Wal-Mart Stores, Inc. f399f7ab-ab51-46ff-bce9-3014eb021930 2022-11-04 Warnings Name fallback generic name: LORATADINE Loratadine ODT LORATADINE Aurohealth LLC 1ba8e521-0b0f-419c-b7c3-fa9586f83f36 2022-11-03 Warnings Name fallback generic name: LORATADINE Loratadine ODT LORATADINE Aurohealth LLC 9f44382f-c289-402d-bb98-ec5fa80fc25d 2022-11-03 Warnings Name fallback generic name: LORATADINE Loratadine ODT LORATADINE Aurohealth LLC 8c119b12-f512-4207-b354-7244d1f9963a 2022-11-03 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Aurohealth LLC 839e2e03-9ebb-4a44-b753-fb174bd36115 2022-11-03 Warnings Name fallback generic name: LORATADINE basic care allergy relief LORATADINE Amazon.com Services LLC a4a7f024-972b-4a16-9cb8-28954c2a74c6 2022-10-18 Warnings Name fallback generic name: LORATADINE dg health allergy relief LORATADINE Dolgencorp, LLC 04258018-3d57-46d7-9595-04786da3f51a 2022-10-13 Warnings Name fallback generic name: LORATADINE welby childrens allergy relief LORATADINE Aldi Inc 402c635d-4116-4767-baa9-e956fed02884 2022-09-26 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Winco Foods, LLC. 2a6cf697-0084-4522-bc89-b3e0f96a598d 2022-08-17 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE WALGREENS CO. 71adc5b3-3a91-4a1f-acb3-78922a7d9d5a 2022-08-09 Warnings Name fallback generic name: LORATADINE Loratadine ODT LORATADINE Aurohealth LLC a6e04fe7-23d3-47d7-9f18-5c4298fbc28b 2022-06-20 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE BluePoint Laboratories adc506ed-7a7a-facc-e053-2a95a90ae147 2022-06-20 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Aurohealth LLC c6bfb54a-04d8-41c1-9fa9-5d4bae0a66d1 2022-06-18 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