Application 218895
- Type
- ANDA
- Sponsor
- REGCON HOLDINGS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A218895-001 | CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2024-10-03 |
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 | A218895-001 | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2024-10-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A218895-001 | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2024-10-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A218895-001 | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2024-10-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A218895-001 | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2024-10-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A218895-001 | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2024-10-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A218895-001 | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2024-10-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A218895-001 | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2024-10-03 | 2680178bc6a6… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A218895-001 | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2024-10-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A218895-001 | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2024-10-03 | d06236e962d9… | ||
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | A218895-001 | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2024-10-03 | 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 |
|---|---|---|---|---|---|---|
| CETIRIZINE HYDROCHLORIDE | CETIRIZINE HYDROCHLORIDE | Indoco Remedies Limited | 2942e093-5077-44d3-b080-8d945d03c55f | 2024-10-07 | Warnings | 218895 ANDA218895 |