Application 090750
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA
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 |
|---|---|---|---|---|---|---|---|
| A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | ||
| A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SOLUTION / ORAL | 2010-02-02 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2010-02-02 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2010-02-02 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2010-02-02 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2010-02-02 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2010-02-02 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2010-02-02 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090750-001 | CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG/5ML | SYRUP / ORAL | 2010-02-02 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090750-002 | CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG/5ML | SYRUP / ORAL | 2010-02-02 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| CHILDRENS ALLERGY RELIEF | CETIRIZINE HYDROCHLORIDE | Fred's, Inc. | 55e799b2-e325-4286-aa9a-b88e99ab1146 | 2020-12-13 | Warnings | 090750 ANDA090750 55315-354 |
| CHILDRENS ALLERGY RELIEF | CETIRIZINE HYDROCHLORIDE | C.D.M.A., Inc. | b4feed95-86ca-411c-99b5-773e485e752f | 2020-12-13 | Warnings | 090750 ANDA090750 63868-865 |
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 |
|---|---|---|---|---|---|
| 55315-354 | CHILDRENS ALLERGY RELIEF | Cetirizine Hydrochloride | Fred's, Inc. | ANDA | Current |
| 55315-354 | CHILDRENS ALLERGY RELIEF | Cetirizine Hydrochloride | Fred's, Inc. | ANDA | Current |
| 55315-354 | CHILDRENS ALLERGY RELIEF | Cetirizine Hydrochloride | Fred's, Inc. | ANDA | Current |
| 58602-028 | Childrens Cetirizine Hydrochloride Allergy | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-028 | Childrens Cetirizine Hydrochloride Allergy | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-028 | Childrens Cetirizine Hydrochloride Allergy | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-028 | Childrens Cetirizine Hydrochloride Allergy | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-030 | Childrens Cetirizine Hydrochloride Hives Relief | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-030 | Childrens Cetirizine Hydrochloride Hives Relief | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-030 | Childrens Cetirizine Hydrochloride Hives Relief | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-030 | Childrens Cetirizine Hydrochloride Hives Relief | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-422 | Childrens Allergy Relief | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-422 | Childrens Allergy Relief | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-422 | Childrens Allergy Relief | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-422 | Childrens Allergy Relief | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-424 | Childrens Allergy Relief | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-424 | Childrens Allergy Relief | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-424 | Childrens Allergy Relief | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-424 | Childrens Allergy Relief | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 63868-865 | CHILDRENS ALLERGY RELIEF | Cetirizine Hydrochloride | C.D.M.A., Inc. | ANDA | Current |
| 63868-865 | CHILDRENS ALLERGY RELIEF | Cetirizine Hydrochloride | C.D.M.A., Inc. | ANDA | Current |
| 63868-865 | CHILDRENS ALLERGY RELIEF | Cetirizine Hydrochloride | C.D.M.A., Inc. | ANDA | Current |
| 63868-865 | CHILDRENS ALLERGY RELIEF | Cetirizine Hydrochloride | C.D.M.A., Inc. | ANDA | Current |
| 65862-422 | Childrens Cetirizine Hydrochloride Allergy | Cetirizine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |
| 65862-443 | Childrens Cetirizine Hydrochloride Hives Relief | Cetirizine Hydrochloride | Aurobindo Pharma Limited | ANDA | Current |