Application 091567
- Type
- ANDA
- Sponsor
- SUN PHARM INDS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 003 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 005 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 180MG | No | No |
| 006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 180MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2012-02-06 | ||
| A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2012-02-06 |
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 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091567-005 | FEXOFENADINE HYDROCHLORIDE HIVES | 180MG | TABLET / ORAL | 2012-02-06 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A091567-006 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2012-02-06 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091567-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES | 30MG | TABLET / ORAL | 2012-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091567-002 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2012-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091567-003 | FEXOFENADINE HYDROCHLORIDE HIVES | 60MG | TABLET / ORAL | 2012-02-06 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A091567-004 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2012-02-06 | 2680178bc6a6… |
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 |
|---|---|---|---|---|---|---|
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | 58193632-2468-4159-b1a9-c24a489f199f | 2026-06-24 | Warnings | 091567 ANDA091567 |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | OHM LABORATORIES INC. | 1a1afa95-570d-456e-b436-a0fcfaf68517 | 2026-05-05 | Warnings | 091567 ANDA091567 51660-998 |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | CVS PHARMACY, INC | 7bc13851-291a-4582-8261-13c5022fbdd1 | 2024-05-24 | Warnings | 091567 ANDA091567 |
| FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | AMERISOURCE BERGEN | 2a578643-adc1-44ca-83f2-9d48527bd3a4 | 2024-05-14 | Warnings | 091567 ANDA091567 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 51660-998 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | OHM LABORATORIES INC. | ANDA | Current |
| 62756-542 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-542 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-543 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-543 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-545 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-545 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |
| 62756-545 | FEXOFENADINE HYDROCHLORIDE | FEXOFENADINE HYDROCHLORIDE | Sun Pharmaceutical Industries, Inc. | ANDA | Current |