Application 078343
- Type
- ANDA
- Sponsor
- DR REDDYS LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
| 002 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 003 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 10MG | No | No |
| 004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | TABLET;ORAL | 5MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2008-01-15 | ||
| A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2008-01-15 | ||
| A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 10MG | TABLET / ORAL | 2008-01-15 | ||
| A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | CETIRIZINE HYDROCHLORIDE | 5MG | TABLET / ORAL | 2008-01-15 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-08-18 06:07:40 | 2026-07 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078343-001 | CETIRIZINE HYDROCHLORIDE HIVES | 5MG | TABLET / ORAL | 2008-01-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078343-002 | CETIRIZINE HYDROCHLORIDE HIVES | 10MG | TABLET / ORAL | 2008-01-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078343-003 | CETIRIZINE HYDROCHLORIDE ALLERGY | 10MG | TABLET / ORAL | 2008-01-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A078343-004 | CETIRIZINE HYDROCHLORIDE ALLERGY | 5MG | TABLET / ORAL | 2008-01-15 | d8e5a09893c0… |
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 TABLETS | Preferred Pharmaceuticals Inc. | 14a885e5-5e75-4a18-b5bc-6aaa748712db | 2026-03-25 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Proficient Rx LP | 55b1738c-fa72-4cd1-a8e8-be41b12b593d | 2026-03-01 | Warnings | 078343 ANDA078343 71205-709 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Sportpharm LLC | d5297bdb-823c-4318-a797-5311d5cf0df8 | 2026-02-06 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Northwind Health Company, LLC | f70886af-a8a4-63a0-e053-6294a90a2d2c | 2026-01-01 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | VERITYRX, LLC | 42778a1c-6894-8646-e063-6294a90a6cb5 | 2025-10-31 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Bryant Ranch Prepack | e4324124-13f8-4450-9fd6-686bd6e25578 | 2025-10-28 | Warnings | 078343 ANDA078343 71335-9612 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Dr. Reddy's Laboratories Inc. | 206ab55a-3720-6205-d710-6e7953571418 | 2025-07-17 | Warnings | 078343 ANDA078343 |
| cetirizine hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Strategic Sourcing Services LLC | 52b70885-f623-b1c8-29c6-584bff46ed45 | 2025-07-17 | Warnings | 078343 ANDA078343 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Discount Drug Mart, Inc | c7c7e496-3682-c764-88ef-d2a09823f71e | 2025-07-16 | Warnings | 078343 ANDA078343 53943-519 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE TABLETS | Dr. Reddy's Laboratories Inc. | e4eca4df-9ad8-b7c4-b512-bfaed5673789 | 2025-07-16 | Warnings | 078343 ANDA078343 43598-811 |
| Cetirizine Hydrochloride | CETIRIZINE HYDROCHLORIDE | Dr.Reddy's Laboratories Limited | de152651-bfcd-856a-8329-a2ac93a376bc | 2011-09-30 | Warnings | 078343 ANDA078343 55111-699 55111-351 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 43598-811 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-811 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 43598-811 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | Dr. Reddy's Laboratories Inc. | ANDA | Current |
| 49035-010 | Allergy Relief | Cetirizine Hydrochloride Tablets | Wal-Mart Stores Inc | ANDA | Current |
| 53943-519 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Discount Drug Mart, Inc | ANDA | Current |
| 55111-351 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 55111-699 | Cetirizine Hydrochloride | Cetirizine Hydrochloride | Dr.Reddy's Laboratories Limited | ANDA | Current |
| 62011-0307 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0307 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | MCKESSON | ANDA | Current |
| 62011-0307 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0307 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0414 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0414 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 62011-0414 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 68071-2570 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 69842-867 | Allergy Relief | Cetirizine Hydrochloride Tablets | CVS Health Corp. | ANDA | Current |
| 70518-3468 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | REMEDYREPACK INC. | ANDA | Current |
| 70518-3468 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | REMEDYREPACK INC. | ANDA | Current |
| 70518-3468 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | REMEDYREPACK INC. | ANDA | Current |
| 70518-3468 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | REMEDYREPACK INC. | ANDA | Current |
| 70677-0142 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 70677-0142 | cetirizine hydrochloride | Cetirizine Hydrochloride Tablets | Strategic Sourcing Services LLC | ANDA | Current |
| 71205-709 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | Proficient Rx LP | ANDA | Current |
| 71335-9612 | Cetirizine Hydrochloride | Cetirizine Hydrochloride Tablets | Bryant Ranch Prepack | ANDA | Current |