Home Applications 019658 Application 019658
Type NDA
Sponsor BAYER HEALTHCARE LLC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 002 CLARITIN LORATADINE TABLET;ORAL 10MG Yes Yes 003 CLARITIN HIVES RELIEF LORATADINE TABLET;ORAL 10MG Yes Yes
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019658-002 CLARITIN LORATADINE 10MG TABLET / ORAL RLD, RS 2002-11-27 N019658-003 CLARITIN HIVES RELIEF LORATADINE 10MG TABLET / ORAL RLD, RS 2003-11-19
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 3 · 82 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 2026-02-19 14:30 UTC 2026-02 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019658-002 CLARITIN 10MG TABLET / ORAL RLD, RS 2002-11-27 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019658-003 CLARITIN HIVES RELIEF 10MG TABLET / ORAL RLD, RS 2003-11-19 782e0a99824c…
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 1 · 7 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 34 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 11523-0007 Claritin loratadine Bayer HealthCare LLC. NDA Current 11523-0007 Claritin loratadine Bayer HealthCare LLC. NDA Current 11523-0007 Claritin loratadine Bayer HealthCare LLC. NDA Current 11523-0007 Claritin loratadine Bayer HealthCare LLC. NDA Current 11523-0007 Claritin loratadine Bayer HealthCare LLC. NDA Current 11523-1527 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-1527 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-1527 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-4359 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-4359 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-4359 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-6655 Claritin Loratadine Bayer HealthCare LLC NDA Current 11523-6655 Claritin Loratadine Bayer HealthCare LLC NDA Current 11523-6655 Claritin Loratadine Bayer HealthCare LLC NDA Current 11523-7160 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7160 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7160 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7237 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7237 Claritin Loratadine Bayer HealthCare LLC. NDA Current 11523-7237 Claritin Loratadine Bayer HealthCare LLC. NDA Current 52904-630 Claritin loratadine Select Corporation NDA Current 52904-630 Claritin loratadine Select Corporation NDA Current 66715-9732 Lil Drug Store Claritin Loratadine Lil' Drug Store Products, Inc NDA Current 66715-9732 Lil Drug Store Claritin Loratadine Lil' Drug Store Products, Inc NDA Current 66715-9732 Lil Drug Store Claritin Loratadine Lil' Drug Store Products, Inc NDA Current 66715-9732 Lil Drug Store Claritin Loratadine Lil' Drug Store Products, Inc NDA Current 67751-153 Claritin LORATADINE Navajo Manufacturing Company Inc. NDA Current 67751-153 Claritin loratadine Navajo Manufacturing Company NDA Current 67751-153 Claritin LORATADINE Navajo Manufacturing Company Inc. NDA Current 67751-153 Claritin loratadine Navajo Manufacturing Company NDA Current 70264-030 Claritin Loratadine R J General Corporation NDA Current 70518-2951 Claritin Loratadine REMEDYREPACK INC. NDA Current 70518-2951 Claritin Loratadine REMEDYREPACK INC. NDA Current 73097-005 Claritin loratadine Savings Distributors LLC NDA Current