Home Applications 075209 Application 075209
Type ANDA
Sponsor PLD ACQUISITIONS LLC 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 A075209-001 LORATADINE LORATADINE 10MG TABLET / ORAL 2003-01-21
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 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075209-001 LORATADINE 10MG TABLET / ORAL 2003-01-21 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 2 · 24 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 2 · 90 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-0858 Indoor Outdoor Allergy Relief Loratadine Walgreens ANDA Current 0363-0858 Indoor Outdoor Allergy Relief Loratadine Walgreens ANDA Current 0363-0858 Indoor Outdoor Allergy Relief Loratadine Walgreens ANDA Current 0363-9150 Wal-itin Loratadine Walgreens ANDA Current 0363-9150 Wal-itin Loratadine Walgreens ANDA Current 0363-9150 Wal-itin Loratadine Walgreens ANDA Current 0363-9150 Wal-itin Loratadine Walgreens ANDA Current 0363-9150 Wal-itin Loratadine Walgreens ANDA Current 0615-5586 Loratadine Loratadine NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0615-5586 Loratadine Loratadine NCS HealthCare of KY, Inc dba Vangard Labs ANDA Current 0781-5077 Loratadine Loratadine Sandoz Inc ANDA Current 11523-0800 Claritin loratadine Bayer HealthCare LLC. ANDA Current 11523-0800 Claritin loratadine Bayer HealthCare LLC. ANDA Current 11822-3276 Allergy Relief Loratadine Rite Aid Corporation ANDA Current 11822-3276 Allergy Relief Loratadine Rite Aid Corporation ANDA Current 11822-3276 Allergy Relief Loratadine Rite Aid Corporation ANDA Current 11822-3276 Allergy Relief Loratadine Rite Aid Corporation ANDA Current 16714-482 Loratadine Loratadine Northstar RxLLC ANDA Current 49035-260 Loratadine Loratadine Wal-Mart ANDA Current 49348-112 Loratadine Loratadine Sunmark ANDA Current 50090-3464 Loratadine Loratadine A-S Medication Solutions ANDA Current 50090-3620 Loratadine Loratadine A-S Medication Solutions ANDA Current 50090-3620 Loratadine Loratadine A-S Medication Solutions ANDA Current 50090-4148 Allergy Relief Loratadine A-S Medication Solutions ANDA Current 50090-4148 Allergy Relief Loratadine A-S Medication Solutions ANDA Current 50090-4148 Allergy Relief Loratadine A-S Medication Solutions ANDA Current 50090-4148 Allergy Relief Loratadine A-S Medication Solutions ANDA Current 50090-4266 Allergy Relief Loratadine A-S Medication Solutions ANDA Current 50090-5067 Allergy Relief Loratadine A-S Medication Solutions ANDA Current 50090-6164 Allergy relief Loratadine A-S Medication Solutions ANDA Current 54473-166 CounterAct Loratadine Melaleuca, Inc. ANDA Current 57896-658 Allergy relief Loratadine Geri-Care Pharmaceutical Corp ANDA Current 57896-658 Allergy relief Loratadine Geri-Care Pharmaceutical Corp ANDA Current 57896-687 Allergy relief Loratadine Geri-Care Pharmaceutical Corp ANDA Current 57896-687 Allergy relief Loratadine Geri-Care Pharmaceutical Corp ANDA Current 59726-758 All Day Allergy Relief Loratadine P & L Development, LLC ANDA Current 59726-758 All Day Allergy Relief Loratadine P & L Development, LLC ANDA Current 59726-758 All Day Allergy Relief Loratadine P & L Development, LLC ANDA Current 59726-915 All Day Allergy Relief Loratadine P & L Development, LLC ANDA Current 59726-915 All Day Allergy Relief Loratadine P & L Development, LLC ANDA Current 59726-915 All Day Allergy Relief Loratadine P & L Development, LLC ANDA Current 60760-569 Allergy Relief Loratadine St Mary's Medical Park Pharmacy ANDA Current 60760-650 Loratadine Loratadine St. Mary ANDA Current 62011-0258 Loratadine Loratadine HealthMart ANDA Current 63548-0753 Loratadine Loratadine PLD Acquisitions LLC DBA Av ANDA Current 63548-0753 Loratadine Loratadine PLD Acquisitions LLC DBA Av ANDA Current 63654-407 Allergy Relief Loratadine Selder, S.A. de C.V. ANDA Current 63868-414 Allergy Relief Loratadine QUALITY CHOICE (Chain Drug Marketing Association) ANDA Current 63868-414 Allergy Relief Loratadine QUALITY CHOICE (Chain Drug Marketing Association) ANDA Current 63868-462 Allergy Relief Loratadine QUALITY CHOICE (Chain Drug Marketing Association) ANDA Current 63868-462 Allergy Relief Loratadine QUALITY CHOICE (Chain Drug Marketing Association) ANDA Current 63868-462 Allergy Relief Loratadine QUALITY CHOICE (Chain Drug Marketing Association) ANDA Current 63868-577 Allergy Relief Loratadine QUALITY CHOICE (Chain Drug Marketing Association) ANDA Current 63868-577 Allergy Relief Loratadine QUALITY CHOICE (Chain Drug Marketing Association) ANDA Current 66715-9742 Claritin loratadine tablet Lil' Drug Store Products, Inc. ANDA Current 67046-453 Loratadine Loratadine Contract Pharmacy Services-PA ANDA Current 67091-350 Allergy Relief Loratadine WinCo Foods, LLC ANDA Current 67091-350 Allergy Relief Loratadine WinCo Foods, LLC ANDA Current 68071-2208 Loratadine Loratadine NuCare Pharmaceuticals,Inc. ANDA Current 68071-2208 Loratadine Loratadine NuCare Pharmaceuticals,Inc. ANDA Current 68071-2208 Loratadine Loratadine NuCare Pharmaceuticals,Inc. ANDA Current 68071-2208 Loratadine Loratadine NuCare Pharmaceuticals,Inc. ANDA Current 68071-2208 Loratadine Loratadine NuCare Pharmaceuticals,Inc. ANDA Current 68071-2392 Loratadine Loratadine NuCare Pharmaceuticals,Inc. ANDA Current 68071-3203 Loratadine Loratadine NuCare Pharmaceuticals, Inc. ANDA Current 68788-7769 Allergy Relief Loratadine Preferred Pharmaceuticals, Inc. ANDA Current 68788-7769 Allergy Relief Loratadine Preferred Pharmaceuticals, Inc. ANDA Current 68788-7769 Allergy Relief Loratadine Preferred Pharmaceuticals, Inc. ANDA Current 69168-407 Allergy Relief Loratadine Allegiant Health ANDA Current 69230-312 Allergy Relief Loratadine Camber Consumer Care ANDA Current 69230-312 Allergy Relief Loratadine Camber Consumer Care ANDA Current 69230-312 Allergy Relief Loratadine Camber Consumer Care ANDA Current 69230-312 Allergy Relief Loratadine Camber Consumer Care ANDA Current 69230-317 Allergy Relief Loratadine Camber Consumer Care ANDA Current 69230-317 Allergy Relief Loratadine Camber Consumer Care ANDA Current 69230-317 Allergy Relief Loratadine Camber Consumer Care ANDA Current 70518-0325 Loratadine Loratadine REMEDYREPACK INC. ANDA Current 70518-0325 Loratadine Loratadine REMEDYREPACK INC. ANDA Current 70677-0145 All Day Allergy Relief Loratadine Strategic Sourcing Services LLC ANDA Current 70677-0145 All Day Allergy Relief Loratadine Strategic Sourcing Services LLC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 8565 ORIG 2003-07-24