Application 211718
- Type
- ANDA
- Sponsor
- HETERO LABS LTD V
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | LORATADINE | LORATADINE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A211718-001 | LORATADINE | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 |
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.
| 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 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 8072bd15b7f6… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | 9b2671bbb829… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A211718-001 | LORATADINE | 10MG | TABLET / ORAL | 2023-07-28 | a50c72e98297… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Loratadine | LORATADINE | Preferred Pharmaceuticals Inc. | d778c4d2-184a-4dc8-9351-66d81d0618f2 | 2026-05-28 | Warnings | 211718 ANDA211718 |
| Loratadine | LORATADINE | AvPAK | 52581dd2-9597-35cb-e063-6294a90a36c7 | 2026-05-21 | Warnings | 211718 ANDA211718 |
| Loratadine | LORATADINE | Bryant Ranch Prepack | baad51cd-daa0-4920-a6d5-2faaaaea7956 | 2025-06-18 | Warnings | 211718 ANDA211718 |
| Loratadine | LORATADINE | Bryant Ranch Prepack | 7f97595b-9df7-4834-82f0-5e4ce329c118 | 2025-01-21 | Warnings | 211718 ANDA211718 |
| Loratadine | LORATADINE | Camber Consumer Care Inc | d57da4bd-af37-414a-a50c-e80d2bb28314 | 2023-09-08 | Warnings | 211718 ANDA211718 |
| Allergy Relief | LORATADINE | Allegiant Health | f0db3a13-43e6-4243-9a3a-7808ddd005e1 | 2020-06-16 | Warnings | 211718 ANDA211718 |