Home Applications 076301 Application 076301
Type ANDA
Sponsor PERRIGO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LORATADINE LORATADINE TABLET;ORAL 10MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A076301-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2004-06-25
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 · 41 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 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 cb3db0bc1861…
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 3 · 43 matching rows.
NDC Listings For This Application# NDC listings for this application page 2 of 3 · 207 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 50090-0836 Loratadine Loratadine A-S Medication Solutions ANDA Current 50090-0836 Loratadine Loratadine A-S Medication Solutions ANDA Current 50090-0836 Loratadine Loratadine A-S Medication Solutions ANDA Current 50090-0837 Loratadine Loratadine A-S Medication Solutions ANDA Current 50090-0837 Loratadine Loratadine A-S Medication Solutions ANDA Current 50090-3943 allergy Loratadine A-S Medication Solutions ANDA Current 50090-3943 allergy Loratadine A-S Medication Solutions ANDA Current 50090-4300 Loratadine Loratadine A-S Medication Solutions ANDA Current 50090-4316 Loratadine Loratadine A-S Medication Solutions ANDA Current 50090-4316 Loratadine Loratadine A-S Medication Solutions ANDA Current 50090-5506 Sunmark Loratadine Loratadine A-S Medication Solutions ANDA Current 50090-5532 Loratadine Loratadine A-S Medication Solutions ANDA Current 50436-3501 Loratadine Loratadine Unit Dose Services ANDA Current 50436-3502 Loratadine Loratadine Unit Dose Services ANDA Current 50594-010 Sound Body Allergy Relief Loratadine Big Lots Stores, Inc. ANDA Current 50594-010 Sound Body Allergy Relief Loratadine Big Lots Stores, Inc. ANDA Current 50594-010 Sound Body Allergy Relief Loratadine Big Lots Stores, Inc. ANDA Current 52959-740 Loratadine Loratadine H.J. Harkins Company, Inc. ANDA Current 53117-612 fad first aid direct allergy relief Loratadine First Aid Direct ANDA Current 53808-0457 Loratadine Loratadine State of Florida DOH Central Pharmacy ANDA Current 55154-8082 Loratadine Loratadine Cardinal Health 107, LLC ANDA Current 55154-8082 Loratadine Loratadine Cardinal Health ANDA Current 55301-612 exchange select allergy relief Loratadine Army & Air Force Exchange Service ANDA Current 55301-612 exchange select allergy relief Loratadine Army & Air Force Exchange Service ANDA Current 55316-612 Healthy accents allergy relief Loratadine DZA Brands LLC ANDA Current 55316-612 Healthy accents allergy relief Loratadine DZA Brands LLC ANDA Current 55319-099 family wellness allergy relief Loratadine Family Dollar Services Inc ANDA Current 55319-099 family wellness allergy relief Loratadine Family Dollar Services Inc ANDA Current 55319-099 family wellness allergy relief Loratadine Family Dollar Services Inc ANDA Current 55319-099 family wellness allergy relief Loratadine Family Dollar Services Inc ANDA Current 55910-612 rexall allergy relief Loratadine Dolgencorp, LLC ANDA Current 55910-612 rexall allergy relief Loratadine Dolgencorp, LLC ANDA Current 55910-806 dg health allergy relief Loratadine Dolgencorp, LLC ANDA Current 55910-806 dg health allergy relief Loratadine Dolgencorp, LLC ANDA Current 55910-806 dg health allergy relief Loratadine Dolgencorp, LLC ANDA Current 57896-688 Allergy relief Loratadine Geri-Care Pharmaceutical Corp ANDA Current 57896-688 Allergy relief Loratadine Geri-Care Pharmaceutical Corp ANDA Current 59779-612 allergy relief Loratadine CVS Pharmacy ANDA Current 59779-612 allergy relief Loratadine CVS Pharmacy ANDA Current 59779-612 allergy relief Loratadine CVS Pharmacy ANDA Current 59779-612 allergy relief Loratadine CVS Pharmacy ANDA Current 61715-118 Preferred Plus Allergy Relief Loratadine Kinray ANDA Current 61715-118 Preferred Plus Allergy Relief Loratadine Kinray ANDA Current 61919-142 LORATADINE LORATADINE DIRECT RX ANDA Current 61919-142 LORATADINE LORATADINE DirectRx ANDA Current 61919-142 LORATADINE LORATADINE DirectRx ANDA Current 61919-142 LORATADINE LORATADINE DirectRx ANDA Current 61919-142 LORATADINE LORATADINE DirectRx ANDA Current 62011-0248 health mart loratadine Loratadine McKesson ANDA Current 62011-0248 health mart loratadine Loratadine Strategic Sourcing Services LLC ANDA Current 62011-0248 health mart loratadine Loratadine Strategic Sourcing Services LLC ANDA Current 62011-0248 health mart loratadine Loratadine Strategic Sourcing Services LLC ANDA Current 62011-0248 health mart loratadine Loratadine Strategic Sourcing Services LLC ANDA Current 62011-0248 health mart loratadine Loratadine Strategic Sourcing Services LLC ANDA Current 63187-601 Loratadine Loratadine Proficient Rx LP ANDA Current 63187-601 Loratadine Loratadine Proficient Rx LP ANDA Current 63187-601 Loratadine Loratadine Proficient Rx LP ANDA Current 63187-601 Loratadine Loratadine Proficient Rx LP ANDA Current 63629-1329 Loratadine Loratadine Bryant Ranch Prepack ANDA Current 63629-1329 Loratadine Loratadine Bryant Ranch Prepack ANDA Current 63940-101 harmon face values allergy relief Loratadine Harmon Stores Inc. ANDA Current 63940-904 Core Values Allergy Relief Loratadine Harmon Stores Inc. ANDA Current 63940-904 Core Values Allergy Relief Loratadine Harmon Stores Inc. ANDA Current 63981-612 kirkland signature allerclear Loratadine Costco Wholesale Company ANDA Current 63981-612 kirkland signature allerclear Loratadine Costco Wholesale Company ANDA Current 63981-612 kirkland signature allerclear Loratadine Costco Wholesale Company ANDA Current 63981-612 kirkland signature allerclear Loratadine Costco Wholesale Company ANDA Current 64024-703 welby all day allergy relief Loratadine Aldi, Inc ANDA Current 66267-653 Loratadine Loratadine NuCare Pharmaceuticals,Inc. ANDA Current 66267-653 Loratadine Loratadine NuCare Pharmaceuticals,Inc. ANDA Current 68196-301 Members Mark Aller-itin Loratadine Sam's West Inc ANDA Current 68196-612 Members Mark Loratadine Loratadine Sam's West Inc ANDA Current 68196-612 Members Mark Loratadine Loratadine Sam's West Inc ANDA Current 68391-314 Berkley and Jensen Allergy Relief Loratadine BJWC ANDA Current 68391-314 Berkley and Jensen Allergy Relief Loratadine BJWC ANDA Current 68391-314 Berkley and Jensen Allergy Relief Loratadine BJWC ANDA Current 68788-7653 Loratadine Loratadine Preferred Pharmaceuticals, Inc. ANDA Current 68788-7653 Loratadine Loratadine Preferred Pharmaceuticals, Inc. ANDA Current 68788-7653 Loratadine Loratadine Preferred Pharmaceuticals, Inc. ANDA Current 68788-9080 Loratadine Loratadine Preferred Pharmaceuticals, Inc. ANDA Current