Application 090765
- Type
- ANDA
- Sponsor
- AMNEAL PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | SYRUP;ORAL | 5MG/5ML | No | No |
| 002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | SYRUP;ORAL | 5MG/5ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | ||
| A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 |
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 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2009-10-07 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2009-10-07 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2009-10-07 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2009-10-07 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2009-10-07 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2009-10-07 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2009-10-07 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2009-10-07 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2009-10-07 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2009-10-07 | bb7c543d1eb4… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2009-10-07 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090765-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2009-10-07 | 782e0a99824c… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090765-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2009-10-07 | 782e0a99824c… |
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 | Amneal Pharmaceuticals LLC | e01f0db4-1b49-4b6e-b2fc-61834897bdd3 | 2024-10-23 | Warnings | 090765 ANDA090765 65162-005 |
| Cetirizine Hydrochloride | CETIRIZINE | Amneal Pharmaceuticals LLC | 7d16ccca-6aa3-4575-9fa7-f57301801a81 | 2024-10-23 | Warnings | 090765 ANDA090765 65162-003 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 65162-003 | Cetirizine Hydrochloride | Cetirizine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-003 | Cetirizine Hydrochloride | Cetirizine | Amneal Pharmaceuticals of New York, LLC | ANDA | Current |
| 65162-003 | Cetirizine Hydrochloride | Cetirizine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-003 | Cetirizine Hydrochloride | Cetirizine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-005 | Cetirizine Hydrochloride | Cetirizine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-005 | Cetirizine Hydrochloride | Cetirizine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-005 | Cetirizine Hydrochloride | Cetirizine | Amneal Pharmaceuticals LLC | ANDA | Current |
| 65162-005 | Cetirizine Hydrochloride | Cetirizine | Amneal Pharmaceuticals of New York, LLC | ANDA | Current |