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 42 .
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 · 42 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 2026-08-18 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…2022-09-29 23:25 UTC 2022-09 N021952-001 CLARITIN 10MG CAPSULE / ORAL RLD, RS 2008-06-16 e64feba35796…
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 1 of 18 · 343 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join All Day Allergy Relief LORATADINE Safeway, Inc. 9e581ae1-d1e6-4038-86e8-fd0c5ab9878a 2026-08-19 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Major Pharmaceuticals 98e41ae1-677a-4583-9a0a-edba29ebbc30 2026-08-07 Warnings Name fallback generic name: LORATADINE Loratadine ODT LORATADINE Rugby Laboratories f59f3400-da77-4eb7-be02-842071d87fae 2026-08-07 Warnings Name fallback generic name: LORATADINE Dye-Free Childrens Loratadine LORATADINE CVS PHARMACY, INC 2e75a831-eccc-4179-a4e3-9844be24bcda 2026-08-05 Warnings Name fallback generic name: LORATADINE Dye-Free Childrens Loratadine LORATADINE CVS PHARMACY, INC af6e6e60-8e39-45a8-bb76-50403aef9668 2026-08-04 Warnings Name fallback generic name: LORATADINE allergy relief LORATADINE Walgreen Company 41f8fc1d-2d14-48da-a233-23e9c11296d9 2026-07-23 Warnings Name fallback generic name: LORATADINE Allergy Relief LORATADINE Dr. Reddy's Laboratories Inc. 44da36d2-1881-e779-d3a2-13ea828f9240 2026-07-15 Warnings Name fallback generic name: LORATADINE Childrens Loratadine LORATADINE Sun Pharmaceutical Industries, Inc. 12c8066a-3429-481e-b63a-7ea2b439a170 2026-07-14 Warnings Name fallback generic name: LORATADINE Childrens Loratadine Sugar Free LORATADINE Sun Pharmaceutical Industries, Inc. 96a76906-58ad-40cd-be27-4ea254e298c5 2026-07-14 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE NuCare Pharmaceuticals, Inc. 569a35be-d653-181c-e063-6294a90a6eb9 2026-07-14 Warnings Name fallback generic name: LORATADINE ALLERGY RELIEF LORATADINE Meijer, Inc. 190ecdc3-454a-4623-9e4a-09f4ab865084 2026-07-09 Warnings Name fallback generic name: LORATADINE dg health allergy relief LORATADINE Dolgencorp Inc dfc4b065-1980-48ec-9c3e-aaa4a42214d3 2026-07-02 Warnings Name fallback generic name: LORATADINE CareOne Allergy Relief 24 Hour LORATADINE American Sales Company bbd5424f-fa5b-4955-8542-7011b19400ea 2026-07-01 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE St. Mary's Medical Park Pharmacy 2bc586e4-5297-44cf-e063-6294a90a531d 2026-06-29 Warnings Name fallback generic name: LORATADINE childrens allergy relief LORATADINE Kroger Company 52934db1-b6fc-43ca-9a8c-66ff47a94745 2026-06-29 Warnings Name fallback generic name: LORATADINE All Day Allergy Relief LORATADINE WALMART INC. (see also Equate) db815af2-4193-4fd9-a028-4a9d54325ca8 2026-06-18 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Cardinal Health 107, LLC 64489b01-a4a7-4c6d-ac84-1dfbd1388d84 2026-06-04 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Preferred Pharmaceuticals Inc. d778c4d2-184a-4dc8-9351-66d81d0618f2 2026-05-28 Warnings Name fallback generic name: LORATADINE Good Sense childrens allergy relief LORATADINE Preferred Pharmaceuticals Inc. 27bb0a40-35ee-4c19-bd6f-fb054c8a2586 2026-05-28 Warnings Name fallback generic name: LORATADINE Loratadine LORATADINE Preferred Pharmaceuticals Inc 0a0d700d-bdba-4c90-a947-5d61d40ce4df 2026-05-28 Warnings Name fallback generic name: LORATADINE
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