Home Applications 076805 Application 076805
Type ANDA
Sponsor TARO Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LORATADINE LORATADINE SYRUP;ORAL 1MG/ML 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 A076805-001 LORATADINE LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20
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 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A076805-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-08-20 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 1 · 15 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 93 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-2085 Wal-itin Allergy Relief Loratadine Walgreen Company ANDA Current 0363-2092 Childrens Wal-itin Loratadine Walgreen Company ANDA Current 0363-2131 Childrens Loratadine Loratadine Walgreen Company ANDA Current 0904-6632 Childrens Loratadine Loratadine Major Pharmaceuticals ANDA Current 11673-092 Childrens Loratadine Loratadine Target Corporation ANDA Current 11673-914 Childrens Loratadine Loratadine Target Corporation ANDA Current 11822-0098 Childrens Allergy Relief Loratadine Rite Aid Corporation ANDA Current 11822-0850 Childrens Loratadine Loratadine Rite Aid Corporation ANDA Current 11822-2092 Childrens Allergy Relief Loratadine Rite Aid Corporation ANDA Current 11822-2131 Childrens Loratadine Loratadine Rite Aid Corporation ANDA Current 21130-092 Childrens Non-Drowsy Loratadine Safeway Inc. ANDA Current 21130-139 Childrens Loratadine Loratadine Safeway Inc. ANDA Current 21130-787 Childrens Non-Drowsy Loratadine Safeway Inc. ANDA Current 21695-498 Loratadine Loratadine Rebel Distributors Corp ANDA Current 24385-531 Good Neighbor Pharmacy Loratadine AmerisourceBergen ANDA Current 24385-531 Good Neighbor Pharmacy Loratadine AmerisourceBergen ANDA Current 24385-543 Good Neighbor Pharmacy Loratadine AmerisourceBergen ANDA Current 24385-543 Good Neighbor Pharmacy Loratadine AmerisourceBergen ANDA Current 30142-017 Childrens Loratadine Loratadine Kroger Company ANDA Current 30142-085 Allergy Relief Loratadine Kroger Company ANDA Current 30142-092 Childrens Non-Drowsy Loratadine Kroger Company ANDA Current 33261-908 Childrens Loratadine Loratadine Aidarex Pharmaceuticals LLC ANDA Current 36800-092 TopCare Loratadine Topco Associates LLC ANDA Current 36800-131 Childrens Loratadine Loratadine Topco Associates LLC ANDA Current 37205-378 Loratadine Loratadine Cardinal Health ANDA Current 37205-378 Loratadine Loratadine Cardinal Health ANDA Current 37205-570 Leader Childrens Allergy Relief Loratadine Cardinal Health ANDA Current 37808-085 Allergy Relief Loratadine H E B ANDA Current 37808-092 Allergy Relief Loratadine H E B ANDA Current 37808-131 Childrens Loratadine Loratadine H E B ANDA Current 41163-092 equaline Loratadine Supervalu Inc ANDA Current 41163-426 Childrens allergy relief Loratadine Supervalu Inc ANDA Current 41250-085 Childrens 24 hour allergy Loratadine Meijer Distribution Inc ANDA Current 41250-583 Childrens Loratadine Loratadine Meijer Distribution Inc ANDA Current 41250-999 meijer Loratadine Meijer Distribution Inc ANDA Current 41520-085 Childrens Loratadine Loratadine American Sales Company ANDA Current 41520-092 Care One Loratadine American Sales Company ANDA Current 41520-131 Childrens Loratadine Loratadine American Sales Company ANDA Current 41520-131 Childrens Loratadine Loratadine American Sales Company ANDA Current 42507-448 Hy-Vee Loratadine HYVEE INC ANDA Current 46122-164 Good Neighbor Pharmacy Loratadine AmerisourceBergen ANDA Current 46122-423 Childrens Loratadine Loratadine AmerisourceBergen ANDA Current 49035-061 Childrens Loratadine Loratadine Wal-Mart Stores Inc ANDA Current 49035-092 equate Loratadine Wal-Mart Stores Inc ANDA Current 49035-183 Childrens allergy relief Loratadine Wal-Mart Stores Inc ANDA Current 49348-333 sunmark Loratadine McKesson ANDA Current 49348-636 Sunmark Loratadine Strategic Sourcing Services LLC ANDA Current 49348-636 Sunmark Loratadine McKesson ANDA Current 49348-849 Sunmark Loratadine McKesson ANDA Current 49614-174 Allergy Relief Loratadine Medicine Shoppe International Inc ANDA Current 50804-092 Good Sense Loratadine Geiss, Destin & Dunn, Inc. ANDA Current 51143-092 Live Better Loratadine The Great Atlantic & Pacific Tea Company ANDA Current 51672-2073 Childrens Loratadine Loratadine Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-2073 Childrens Loratadine Loratadine Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-2085 Childrens Loratadine Loratadine Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-2085 Childrens Loratadine Loratadine Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-2092 Childrens Loratadine Loratadine Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-2092 Childrens Loratadine Loratadine Taro Pharmaceuticals U.S.A., Inc. ANDA Current 51672-2131 Childrens Loratadine Loratadine Taro Pharmaceuticals U.S.A., Inc. ANDA Current 55312-092 Western Family Loratadine Western Family Foods Inc ANDA Current 56062-092 childrens allergy Loratadine Publix Super Markets Inc ANDA Current 56062-132 childrens allergy Loratadine Publix Super Markets Inc ANDA Current 56062-132 childrens allergy Loratadine Publix Super Markets Inc ANDA Current 59779-093 Childrens Loratadine CVS Pharmacy ANDA Current 59779-446 Childrens Allergy Relief Loratadine CVS Pharmacy ANDA Current 61715-156 Preferred Plus (Kinray) Loratadine Preferred Plus (Kinray) ANDA Current 62011-0072 Health Mart Pharmacy Childrens Loratadine Loratadine Health Mart ANDA Current 62011-0181 HealthMart Loratadine McKesson ANDA Current 62011-0305 Childrens Loratadine Loratadine Strategic Sourcing Services LLC ANDA Current 62011-0305 Childrens Loratadine Loratadine Health Mart ANDA Current 62011-0348 Childrens Loratadine Loratadine Strategic Sourcing Services LLC ANDA Current 62011-0348 Childrens Loratadine Loratadine Health Mart ANDA Current 63777-073 Childrens Loratadine Loratadine Kinray, Inc. ANDA Current 63868-092 Quality Choice Loratadine Chain Drug Marketing Association, Inc. ANDA Current 63868-156 Quality Choice Loratadine Chain Drug Marketing Association ANDA Current 63941-085 Best Choice Childrens Loratadine Loratadine Valu Merchandisers Company ANDA Current 63941-092 Best Choice Childrens Loratadine Loratadine Valu Merchandisers Company ANDA Current 63941-131 Childrens Loratadine Loratadine Valu Merchandisers Company ANDA Current 68016-085 Premier Value Loratadine Chain Drug Constortium ANDA Current 68016-131 Childrens Loratadine Loratadine Pharmacy Value Alliance LLC ANDA Current