Home Applications 208314 Application 208314
Type ANDA
Sponsor AUROBINDO PHARMA LTD 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 A208314-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2018-04-16
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 · 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 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208314-001 LORATADINE 10MG TABLET / ORAL 2018-04-16 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 · 20 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 46 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-9603 Loratadine Loratadine WALGREEN CO. ANDA Current 0363-9603 Loratadine Loratadine WALGREEN CO. ANDA Current 30142-066 Loratadine Loratadine KROGER COMPANY ANDA Current 30142-066 Loratadine Loratadine KROGER COMPANY ANDA Current 50268-489 Loratadine Loratadine AvPAK ANDA Current 50268-489 Loratadine Loratadine AvPAK ANDA Current 50268-489 Loratadine Loratadine AvPAK ANDA Current 57243-200 Loratadine Loratadine McLane Company, Inc. ANDA Current 57243-200 Loratadine Loratadine McLane Company, Inc. ANDA Current 57243-200 Loratadine Loratadine McLane Company, Inc. ANDA Current 58602-702 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-702 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-702 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-702 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-702 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-702 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-702 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-831 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-831 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-831 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-847 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-847 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-847 Loratadine Loratadine Aurohealth LLC ANDA Current 58602-847 Loratadine Loratadine Aurohealth LLC ANDA Current 67091-408 Loratadine Loratadine Winco Foods, LLC. ANDA Current 68001-438 Loratadine Loratadine BluePoint Laboratories ANDA Current 68001-438 Loratadine Loratadine BluePoint Laboratories ANDA Current 68001-438 Loratadine Loratadine BluePoint Laboratories ANDA Current 68016-094 Loratadine Loratadine Chain Drug Consortium, LLC ANDA Current 68016-094 Loratadine Loratadine Chain Drug Consortium, LLC ANDA Current 68016-094 Loratadine Loratadine Chain Drug Consortium, LLC ANDA Current 68016-094 Loratadine Loratadine Chain Drug Consortium, LLC ANDA Current 68016-094 Loratadine Loratadine Chain Drug Consortium, LLC ANDA Current 69842-242 Loratadine Loratadine CVS Pharmacy, Inc. ANDA Current 69842-242 Loratadine Loratadine CVS Pharmacy, Inc. ANDA Current 69842-242 Loratadine Loratadine CVS Pharmacy, Inc. ANDA Current 69842-242 Loratadine Loratadine CVS Pharmacy, Inc. ANDA Current 69842-242 Loratadine Loratadine CVS Pharmacy, Inc. ANDA Current 69842-242 Loratadine Loratadine CVS Pharmacy, Inc. ANDA Current 70000-0583 Loratadine Loratadine Cardinal Health ANDA Current 70000-0583 Loratadine Loratadine Cardinal Health ANDA Current 73581-203 ALLERGY RELIEF LORATADINE YYBA CORP ANDA Current 73581-203 ALLERGY RELIEF LORATADINE YYBA CORP ANDA Current 73581-203 ALLERGY RELIEF LORATADINE YYBA CORP ANDA Current 73581-203 ALLERGY RELIEF LORATADINE YYBA CORP ANDA Current 73581-203 ALLERGY RELIEF LORATADINE YYBA CORP ANDA Current