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 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 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 · 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 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 A076301-001 LORATADINE 10MG TABLET / ORAL 2004-06-25 caaa826d4ba7…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…
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 2 of 3 · 41 matching rows.
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 3 · 207 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0113-0612 good sense allergy relief Loratadine L. Perrigo Company ANDA Current 0113-0612 good sense allergy relief Loratadine L. Perrigo Company ANDA Current 0113-0612 good sense allergy relief Loratadine L. Perrigo Company ANDA Current 0113-0612 good sense allergy relief Loratadine L. Perrigo Company ANDA Current 0113-1612 good sense allergy relief Loratadine L. Perrigo Company ANDA Current 0113-1612 good sense allergy relief Loratadine L. Perrigo Company ANDA Current 0113-7612 Basic Care allergy relief Loratadine L. Perrigo Company ANDA Current 0113-7612 Basic Care allergy relief Loratadine L. Perrigo Company ANDA Current 0363-0699 Wal itin Loratadine Walgreen Company ANDA Current 0363-1612 allergy relief Loratadine Walgreen Company ANDA Current 0363-1612 allergy relief Loratadine Walgreen Company ANDA Current 0363-1612 allergy relief Loratadine Walgreen Company ANDA Current 0615-8217 Loratadine Loratadine NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-8217 Loratadine Loratadine NCS HealthCare of KY, LLC dba Vangard Labs ANDA Current 0904-5728 allergy Loratadine Major Pharmaceuticals ANDA Current 0904-5728 allergy Loratadine Major Pharmaceuticals ANDA Current 0904-5728 allergy Loratadine Major Pharmaceuticals ANDA Current 0904-6852 Loratadine Loratadine Major Pharmaceuticals ANDA Current 0904-6852 Loratadine Loratadine Major Pharmaceuticals ANDA Current 0904-6852 Loratadine Loratadine Major Pharmaceuticals ANDA Current 0904-6852 Loratadine Loratadine Major Pharmaceuticals ANDA Current 0904-6852 Loratadine Loratadine Major Pharmaceuticals ANDA Current 10202-612 7 Select Allergy Relief Loratadine 7-Eleven ANDA Current 10202-612 7 Select Allergy Relief Loratadine 7-Eleven ANDA Current 11673-612 up and up allergy relief Loratadine Target Corporation ANDA Current 11673-612 up and up allergy relief Loratadine Target Corporation ANDA Current 11822-0612 allergy relief Loratadine Rite Aid Corporation ANDA Current 11822-0612 allergy relief Loratadine Rite Aid Corporation ANDA Current 11822-0612 allergy relief Loratadine Rite Aid Corporation ANDA Current 16714-898 Loratadine Loratadine Northstar RxLLC ANDA Current 16714-898 Loratadine Loratadine Northstar RxLLC ANDA Current 21130-123 Signature Care Allergy Relief Loratadine Safeway ANDA Current 21130-123 Signature Care Allergy Relief Loratadine Safeway ANDA Current 24385-471 good neighbor pharmacy loratadine Loratadine Amerisource Bergen ANDA Current 24385-471 good neighbor pharmacy loratadine Loratadine Amerisource Bergen ANDA Current 30142-612 Allergy Relief Loratadine Kroger Company ANDA Current 30142-612 Allergy Relief Loratadine Kroger Company ANDA Current 30142-612 Allergy Relief Loratadine Kroger Company ANDA Current 33992-0612 Assured Allergy Relief Loratadine Greenbrier International Inc. ANDA Current 35356-881 Loratadine Loratadine Lake Erie Medical DBA Quality Care Products LLC ANDA Current 35356-881 Loratadine Loratadine Lake Erie Medical DBA Quality Care Products LLC ANDA Current 36800-612 TopCare Allergy Relief Loratadine Topco Associates LLC ANDA Current 36800-612 TopCare Allergy Relief Loratadine Topco Associates LLC ANDA Current 36800-612 TopCare Allergy Relief Loratadine Topco Associates LLC ANDA Current 36800-929 topcare clear time Loratadine Topco Associates LLC ANDA Current 37012-612 Allergy Relief Loratadine Shopko Stores Operating Co., LLC ANDA Current 37012-612 Allergy Relief Loratadine Shopko Stores Operating Co., LLC ANDA Current 41163-612 Equaline Allergy Relief Loratadine Supervalu Inc ANDA Current 41163-612 Equaline Allergy Relief Loratadine Supervalu Inc ANDA Current 41163-612 Equaline Allergy Relief Loratadine Supervalu Inc ANDA Current 41190-612 ShopRite Allergy Relief Loratadine Wakefern Food Corporation ANDA Current 41190-612 ShopRite Allergy Relief Loratadine Wakefern Food Corporation ANDA Current 41250-523 allergy relief Loratadine Meijer Distribution Inc ANDA Current 41250-523 allergy relief Loratadine Meijer Distribution Inc ANDA Current 41250-612 allergy relief Loratadine Meijer Distribution Inc ANDA Current 41520-612 CareOne Allergy Relief Loratadine American Sales Company ANDA Current 41520-612 CareOne Allergy Relief Loratadine American Sales Company ANDA Current 41520-612 CareOne Allergy Relief Loratadine American Sales Company ANDA Current 43353-259 Loratadine Loratadine Aphena Pharma Solutions - Tennessee, LLC ANDA Current 43353-259 Loratadine Loratadine Aphena Pharma Solutions - Tennessee, LLC ANDA Current 43353-259 Loratadine Loratadine Aphena Pharma Solutions - Tennessee, LLC ANDA Current 43353-259 Loratadine Loratadine Aphena Pharma Solutions - Tennessee, LLC ANDA Current 45802-650 Loratadine Loratadine Padagis Israel Pharmaceuticals Ltd ANDA Current 45802-650 Loratadine Loratadine Perrigo New York Inc ANDA Current 45802-650 Loratadine Loratadine Perrigo New York Inc ANDA Current 46994-612 Being Well Allergy Relief Loratadine Save-A-Lot Food Stores Ltd ANDA Current 46994-612 Being Well Allergy Relief Loratadine Save-A-Lot Food Stores Ltd ANDA Current 46994-612 Being Well Allergy Relief Loratadine Save-A-Lot Food Stores Ltd ANDA Current 49035-612 equate allergy relief Loratadine Wal-Mart Stores Inc ANDA Current 49035-612 equate allergy relief Loratadine Wal-Mart Stores Inc ANDA Current 49035-612 equate allergy relief Loratadine Wal-Mart Stores Inc ANDA Current 49348-394 SUNMARK LORATADINE Loratadine Mckesson ANDA Current 49348-394 SUNMARK LORATADINE Loratadine Strategic Sourcing Services LLC ANDA Current 49348-818 Sunmark Loratadine Loratadine McKesson ANDA Current 49348-818 Sunmark Loratadine Loratadine Strategic Sourcing Services LLC ANDA Current 49348-818 Sunmark Loratadine Loratadine Strategic Sourcing Services LLC ANDA Current 49348-818 Sunmark Loratadine Loratadine Strategic Sourcing Services LLC ANDA Current 49349-218 Loratadineantihistamine Loratadine REMEDYREPACK INC. ANDA Current 49738-612 Smart Sense Allergy Relief Loratadine Kmart Corporation ANDA Current 50090-0836 Loratadine Loratadine A-S Medication Solutions ANDA Current