Application 090142
- Type
- ANDA
- Sponsor
- SUN PHARM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG | No | No |
| 002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG | No | No |
| 003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 5MG | No | No |
| 004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET, CHEWABLE;ORAL | 10MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | ||
| A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | ||
| A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | ||
| A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 6a51e52b5d6a… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 1c564ffb4f44… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | ea1830bbd6c7… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | a72a2bbeb626… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 9b2671bbb829… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | a67488948f0b… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 3f0d92c62455… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 053a50430f4f… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 3bdfa0b2c4d7… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 3a93d1ddd44b… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | OHM LABORATORIES INC. | 97802669-b4bd-4807-b3c1-6c6f5a2b0c67 | 2026-06-03 | Warnings | 090142 ANDA090142 51660-066 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 47335-343 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-343 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-343 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-343 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-344 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-344 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-344 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 47335-344 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 51660-066 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | OHM LABORATORIES INC. | ANDA | Current |
| 68016-353 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Chain Drug Consortium, LLC | ANDA | Current |