Home Applications 075565 Application 075565
Type ANDA
Sponsor PHARM ASSOC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LORATADINE LORATADINE SYRUP;ORAL 1MG/ML No No 002 LORATADINE LORATADINE SYRUP; ORAL 5MG/5ML 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 A075565-001 LORATADINE LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05
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 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A075565-001 LORATADINE 1MG/ML SYRUP / ORAL 2004-10-05 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 18 · 347 matching rows.