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 7 of 17 · 339 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Allergy relief LORATADINE Geri-Care Pharmaceutical Corp b66f171a-7b95-b27a-e053-2a95a90a6009 2025-07-28 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Mylan Institutional Inc. 1fc9ddd1-393d-4fe2-a9e0-d192df7331db 2025-07-22 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE STRATEGIC SOURCING SERVICES LLC 6ba7fc5d-81c4-482c-8b38-4a6587853a9f 2025-07-21 Warnings Name fallback generic name: LORATADINE childrens allergy LORATADINE Publix Super Markets Inc fa429380-019e-4ccd-8444-d5d931c4cc65 2025-07-15 Warnings Name fallback generic name: LORATADINE Nuvicare-Allergy Relief Loratadine Tablets, 10 mg LORATADINE NUVICARE LLC 023a46f0-8d1c-4f62-953d-3e6458a54f6e 2025-07-01 Warnings Name fallback generic name: LORATADINE Gencare-Allergy Relief Loratadine Tablets, 10 mg LORATADINE Pioneer Life Sciences, LLC 647dc957-4aee-48f6-bb77-e82d3b380e80 2025-06-30 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Lannett Company, Inc. 069c4e75-1f9f-4ab5-9570-3d93d12c2a23 2025-06-19 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Bryant Ranch Prepack baad51cd-daa0-4920-a6d5-2faaaaea7956 2025-06-18 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Bryant Ranch Prepack 0d74af21-3ef7-418b-a2ef-78737b0af288 2025-06-13 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Bryant Ranch Prepack a5d54183-06a9-4ae1-93b9-e9a2e03ad42b 2025-06-13 Warnings Name fallback generic name: LORATADINE 365 Whole Foods Market Loratadine LORATADINE Whole Foods Market, Inc. bba4e7c8-db8e-4522-915c-48ee809e3bce 2025-06-11 Warnings Name fallback generic name: LORATADINE Loratadine Allergy Relief LORATADINE Asclemed USA, Inc. 332bda00-1350-2d33-e063-6394a90a8bd7 2025-05-21 Warnings Name fallback generic name: LORATADINE Children Claritin Allergy LORATADINE Bayer HealthCare LLC. 170061e9-e529-4ff0-e054-00144ff8d46c 2025-05-15 Warnings Name fallback generic name: LORATADINE basic care childrens allergy relief LORATADINE Amazon.com Services LLC 90f40330-46a6-44cf-9b09-6f791c9b210b 2025-05-12 Warnings Name fallback generic name: LORATADINE non drowsy allergy relief LORATADINE Meijer Distribution Inc 4762c96e-d562-4f74-a275-8cba597987f9 2025-05-08 Warnings Name fallback generic name: LORATADINE Equaline Childrens Allergy Relief LORATADINE United Natural Foods, Inc. dba UNFI 11e889d8-833c-4043-a1af-7ffaf3fda61d 2025-05-07 Warnings Name fallback generic name: LORATADINE childrens allergy relief LORATADINE Meijer Distribution Inc b27f0bd0-4e61-4498-b5b7-54ae31f637f3 2025-05-07 Warnings Name fallback generic name: LORATADINE dg health childrens allergy LORATADINE Dolgencorp, LLC 14acf572-e1f0-40f5-82cf-357cb2f3a051 2025-05-07 Warnings Name fallback generic name: LORATADINE good sense childrens allergy relief LORATADINE L. Perrigo Company 4ce244e2-9fbc-4371-8806-789fd3a61a09 2025-05-06 Warnings Name fallback generic name: LORATADINE childrens allergy relief LORATADINE Meijer, Inc. f71d9155-e5fb-4735-86f6-59dd9abf6be0 2025-05-05 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