Application 090760
- Type
- ANDA
- Sponsor
- AUROBINDO PHARMA LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 003 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 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 |
|---|---|---|---|---|---|---|---|
| A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-08-05 | ||
| A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2015-08-05 | ||
| A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2015-08-05 | ||
| A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2015-08-05 |
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 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090760-001 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2015-08-05 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090760-002 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 5MG | TABLET / ORAL | 2015-08-05 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090760-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2015-08-05 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090760-004 | CETIRIZINE HYDROCHLORIDE HIVES RELIEF | 10MG | TABLET / ORAL | 2015-08-05 | d06236e962d9… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0363-9602 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | WALGREEN CO. | ANDA | Current |
| 0363-9602 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | WALGREEN CO. | ANDA | Current |
| 10202-715 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | 7-Eleven | ANDA | Current |
| 10202-715 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | 7-Eleven | ANDA | Current |
| 16714-799 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-799 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 16714-799 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | NorthStar Rx LLC | ANDA | Current |
| 30142-172 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | KROGER COMPANY | ANDA | Current |
| 30142-172 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | KROGER COMPANY | ANDA | Current |
| 55315-007 | Cetirizine Hydrochloride (Allergy Relief) | Cetirizine Hydrochloride | Fred's, Inc. | ANDA | Current |
| 55315-007 | Cetirizine Hydrochloride (Allergy Relief) | Cetirizine Hydrochloride | Fred's, Inc. | ANDA | Current |
| 55315-007 | Cetirizine Hydrochloride (Allergy Relief) | Cetirizine Hydrochloride | Fred's, Inc. | ANDA | Current |
| 58602-444 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-444 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-444 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-444 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-444 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-444 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-445 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-445 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-445 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-445 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-445 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-445 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-446 | Cetirizine Hydrochloride (Hives Relief) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-446 | Cetirizine Hydrochloride (Hives Relief) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-446 | Cetirizine Hydrochloride (Hives Relief) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-447 | Cetirizine Hydrochloride (Hives Relief) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-447 | Cetirizine Hydrochloride (Hives Relief) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-447 | Cetirizine Hydrochloride (Hives Relief) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-812 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-812 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-812 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-812 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-812 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-812 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-813 | Cetirizine Hydrochloride (Hives Relief) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-813 | Cetirizine Hydrochloride (Hives Relief) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-813 | Cetirizine Hydrochloride (Hives Relief) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-823 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-823 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 58602-823 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Aurohealth LLC | ANDA | Current |
| 62011-0313 | all day allergy | Cetirizine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0313 | all day allergy | Cetirizine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0313 | all day allergy | Cetirizine HCl | McKESSON Corporation | ANDA | Current |
| 68001-436 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68001-436 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | BluePoint Laboratories | ANDA | Current |
| 68071-2482 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 69842-237 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-237 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-237 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | CVS Pharmacy, Inc. | ANDA | Current |
| 69842-237 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | CVS Pharmacy, Inc. | ANDA | Current |
| 70000-0047 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Allergy | Cardinal Health | ANDA | Current |
| 70000-0047 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Allergy | Cardinal Health | ANDA | Current |
| 70000-0047 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Allergy | Cardinal Health | ANDA | Current |
| 70677-0006 | all day allergy | Cetirizine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 70677-0006 | all day allergy | Cetirizine HCl | McKESSON Corporation | ANDA | Current |
| 70677-0006 | all day allergy | Cetirizine HCl | Strategic Sourcing Services LLC | ANDA | Current |
| 80539-002 | Cetirizine Hydrochloride (Allergy) | Cetirizine Hydrochloride | Allwell Health Inc | ANDA | Current |