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 |
|---|---|---|---|---|---|---|---|---|---|
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090142-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090142-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090142-003 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090142-004 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET, CHEWABLE / ORAL | 2011-08-30 | 4b0b4de00fa7… |
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 |