Home Applications 210088 Application 210088
Type ANDA
Sponsor SUN PHARM Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LORATADINE LORATADINE TABLET, CHEWABLE;ORAL 5MG No No 002 LORATADINE LORATADINE TABLET, CHEWABLE;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 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A210088-001 LORATADINE LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 A210088-002 LORATADINE LORATADINE 10MG TABLET, CHEWABLE / ORAL 2025-04-25
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 · 45 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 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A210088-002 LORATADINE 10MG TABLET, CHEWABLE / ORAL 2025-04-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A210088-002 LORATADINE 10MG TABLET, CHEWABLE / ORAL 2025-04-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A210088-002 LORATADINE 10MG TABLET, CHEWABLE / ORAL 2025-04-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A210088-001 LORATADINE 5MG TABLET, CHEWABLE / ORAL 2018-04-16 3a93d1ddd44b…
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 · 38 matching rows.
NDC Listings For This Application# NDC listings for this application page 1 of 1 · 41 matching rows.
NDC, Name, Nonproprietary name table NDC Name Nonproprietary name Labeler Marketing category Status 0363-0752 Loratadine Loratadine WALGREEN COMPANY ANDA Current 0363-0754 Wal-itin LORATADINE Walgreens ANDA Current 0363-9994 Loratadine Loratadine WALGREENS CO. ANDA Current 0363-9994 Loratadine Loratadine WALGREENS CO. ANDA Current 0363-9994 Loratadine Loratadine WALGREENS CO. ANDA Current 0363-9995 Wal-itin LORATADINE WALGREENS CO. ANDA Current 0363-9995 Wal-itin LORATADINE WALGREENS CO. ANDA Current 0363-9995 Wal-itin LORATADINE WALGREENS CO. ANDA Current 11673-111 DYE-FREE CHILDRENS LORATADINE LORATADINE UP & UP ANDA Current 11673-115 Dye-Free Childrens Loratadine LORATADINE UP & UP ANDA Current 11673-996 Childrens Allergy LORATADINE TARGET CORPORATION ANDA Current 11673-996 Childrens Allergy LORATADINE TARGET CORPORATION ANDA Current 11673-997 CHILDRENS LORATADINE LORATADINE TARGET CORPORATION ANDA Current 11673-997 CHILDRENS LORATADINE LORATADINE TARGET CORPORATION ANDA Current 11822-7240 LORATADINE LORATADINE Rite Aid ANDA Current 11822-8329 DYE-FREE CHILDRENS LORATADINE LORATADINE RITE AID ANDA Current 11822-9999 Dye-Free Childrens Loratadine Loratadine RITE AID ANDA Current 21130-646 DYE-FREE CHILDRENS LORATADINE LORATADINE SAFEWAY ANDA Current 21130-999 CHILDRENS LORATADINE LORATADINE SAFEWAY ANDA Current 21130-999 CHILDRENS LORATADINE LORATADINE SAFEWAY ANDA Current 30142-984 Loratadine Loratadine KROGER COMPANY ANDA Current 30142-996 Loratadine Loratadine KROGER COMPANY ANDA Current 46122-550 Childrens Loratadine LORATADINE Amerisource Bergen ANDA Current 49035-953 Loratadine Loratadine Wal-Mart Stores, Inc ANDA Current 49035-953 Loratadine Loratadine Wal-Mart Stores, Inc ANDA Current 51660-106 DYE-FREE CHILDRENS LORATADINE LORATADINE Ohm Laboratories Inc. ANDA Current 51660-112 Dye-Free Childrens Loratadine LORATADINE Ohm Laboratories Inc. ANDA Current 51660-753 Loratadine Loratadine Ohm Laboratories Inc. ANDA Current 51660-753 Loratadine Loratadine Ohm Laboratories Inc. ANDA Current 51660-754 Childrens Loratadine LORATADINE Ohm Laboratories Inc. ANDA Current 51660-754 Childrens Loratadine LORATADINE Ohm Laboratories Inc. ANDA Current 56062-900 DYE-FREE CHILDRENS LORATADINE LORATADINE PUBLIX SUPER MARKETS, INC ANDA Current 56062-990 LORATADINE LORATADINE PUBLIX SUPER MARKETS INC ANDA Current 56062-990 LORATADINE LORATADINE PUBLIX SUPER MARKETS INC ANDA Current 68016-053 Loratadine Loratadine Premier Value ANDA Current 69842-894 Dye-Free Childrens Loratadine Loratadine CVS PHARMACY, INC ANDA Current 69842-895 Dye-Free Childrens Loratadine Loratadine CVS PHARMACY, INC ANDA Current 69842-895 Dye-Free Childrens Loratadine Loratadine CVS PHARMACY, INC ANDA Current 69842-953 CHILDRENS LORATADINE LORATADINE CVS PHARMACY, INC ANDA Current 69842-954 CHILDRENS LORATADINE LORATADINE CVS PHARMACY, INC ANDA Current 79903-008 DYE-FREE CHILDRENS LORATADINE LORATADINE WAL-MART STORES, INC ANDA Current
Documents# Document, Submission type, Date table Document Submission type Date 54168 ORIG 2018-05-11