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 3 of 17 · 339 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join All Day Allergy Relief LORATADINE WALMART INC. (see also Equate) 80958503-400c-422a-a641-e1a3d5a9a6a8 2026-04-17 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Camber Consumer Care Inc 4dec6d48-78e0-48a4-9274-25f6cbf26a2c 2026-04-10 Warnings Name fallback generic name: LORATADINE Childrens Loratadine LORATADINE Sun Pharmaceutical Industries, Inc. 78e11f1c-c8a4-4b2a-b7dc-ae1b2dea26d0 2026-04-08 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE NuCare Pharmaceuticals,Inc. 16f00a3a-0777-f70c-e063-6294a90a71c9 2026-04-06 Warnings Name fallback generic name: LORATADINE ALLERGY RELIEF 10 mg LORATADINE TWIN MED LLC d943f548-aa0d-4476-e053-2a95a90a7bd4 2026-04-01 Warnings Name fallback generic name: LORATADINE ALLERGY RELIEF LORATADINE CARDINAL HEALTH 110, LLC. DBA LEADER 052e0ea2-441f-42cc-b62c-f2574f995bff 2026-03-31 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Safecor Health, LLC 14d1ecf5-d694-4ce0-87e4-df27f3f4d909 2026-03-31 Warnings Name fallback generic name: LORATADINE LORATADINE LORATADINE CVS HEALTH CORP 899800a7-89bc-4a39-88b0-f19d78934daf 2026-03-26 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE CVS Pharmacy, Inc. 3937f769-e8e2-4b32-8338-21b0a74a8697 2026-03-20 Warnings Name fallback generic name: LORATADINE Loratadine Allergy Relief LORATADINE PD-Rx Pharmaceuticals, Inc. 7127b39d-3686-4249-b720-43c02b4c4654 2026-03-19 Warnings Name fallback generic name: LORATADINE Childrens Loratadine Oral LORATADINE A-S Medication Solutions 0a42baae-554b-4b93-8780-fe45c42fabc0 2026-03-18 Warnings Name fallback generic name: LORATADINE CHILDRENS ALLERGY RELIEF LORATADINE CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED 0e84571d-87b6-4742-ac62-9ed68a115c72 2026-03-17 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE NuCare Pharmaceuticals,Inc. c0e3057d-2dd2-de2b-e053-2995a90a1a1d 2026-03-05 Warnings Name fallback generic name: LORATADINE Loratadine antihistamine LORATADINE PD-Rx Pharmaceuticals, Inc. 039f144b-891b-4ab0-e063-6394a90aa4c8 2026-02-26 Warnings Name fallback generic name: LORATADINE Loratadine antihistamine LORATADINE PD-Rx Pharmaceuticals, Inc. 775885f9-0580-4eca-94d8-44fce1dcdccd 2026-02-26 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE ATLANTIC BIOLOGICALS CORP. 999a1080-5bbd-4027-b6e7-a90a6941ee27 2026-02-26 Warnings Name fallback generic name: LORATADINE Dr Simi All Day Allergy Relief LORATADINE Farmacias De Similares TX LLC 3c5b2eaa-24da-3314-e063-6294a90a5b21 2026-02-26 Warnings Name fallback generic name: LORATADINE allergy relief LORATADINE CVS Pharmacy 0038bc38-c205-4d8d-ab78-1abbcd76829e 2026-02-25 Warnings Name fallback generic name: LORATADINE allergy relief LORATADINE Kroger Company 745d48f2-504d-4e3d-abf8-768d201cf814 2026-02-24 Warnings Name fallback generic name: LORATADINE Alavert Allergy LORATADINE Foundation Consumer Brands 039ea563-9796-4270-b84a-50dd25a9d976 2026-02-23 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