Application 204097
- Type
- ANDA
- Sponsor
- HETERO LABS LTD V
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 30MG | No | No |
| 002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | TABLET;ORAL | 60MG | No | No |
| 003 | 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 |
|---|---|---|---|---|---|---|---|
| A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 30MG | TABLET / ORAL | 2016-08-19 | ||
| A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 60MG | TABLET / ORAL | 2016-08-19 | ||
| A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | FEXOFENADINE HYDROCHLORIDE | 180MG | TABLET / ORAL | 2016-08-19 |
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 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204097-002 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 60MG | TABLET / ORAL | 2016-08-19 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A204097-003 | FEXOFENADINE HYDROCHLORIDE ALLERGY | 180MG | TABLET / ORAL | 2016-08-19 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A204097-001 | CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY | 30MG | TABLET / ORAL | 2016-08-19 | 8072bd15b7f6… |
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 HCL | FEXOFENADINE HCL | Camber Consumer Care | e437655c-f1f3-4b58-89ba-bf22e416d311 | 2019-03-06 | Warnings | 204097 ANDA204097 69230-301 69230-300 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 0904-6978 | Allergy Relief | Fexofenadine HCL | Major Pharmaceuticals | ANDA | Current |
| 0904-6978 | Allergy Relief | Fexofenadine HCL | Major Pharmaceuticals | ANDA | Current |
| 16714-899 | Fexofenadine HCL | Fexofenadine HCL | NorthStar RxLLC | ANDA | Current |
| 16714-899 | Fexofenadine HCL | Fexofenadine HCL | NorthStar RxLLC | ANDA | Current |
| 21130-064 | Allergy Relief | Fexofenadine HCl | Safeway, Inc. | ANDA | Current |
| 21130-064 | Allergy Relief | Fexofenadine HCl | Safeway, Inc. | ANDA | Current |
| 21130-064 | Allergy Relief | Fexofenadine HCl | Safeway, Inc. | ANDA | Current |
| 41250-564 | Allergy Relief | Fexofenadine HCl | MEIJER, INC. | ANDA | Current |
| 41250-564 | Allergy Relief | Fexofenadine HCl | MEIJER, INC. | ANDA | Current |
| 41250-564 | Allergy Relief | Fexofenadine HCl | MEIJER, INC. | ANDA | Current |
| 49035-366 | equate allergy relief | fexofenadine hydrochloride | Walmart Inc. | ANDA | Current |
| 49035-366 | equate allergy relief | fexofenadine hydrochloride | Walmart Inc. | ANDA | Current |
| 49035-366 | equate allergy relief | fexofenadine hydrochloride | Walmart Inc. | ANDA | Current |
| 49035-504 | Allergy Relief | Fexofenadine HCL | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 49035-504 | Allergy Relief | Fexofenadine HCL | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | ANDA | Current |
| 49035-504 | Allergy Relief | Fexofenadine HCL | EQUATE (Wal-Mart Stores, Inc.) | ANDA | Current |
| 50090-4070 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4070 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4070 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4070 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4070 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4070 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4267 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 50090-4267 | Fexofenadine HCL | Fexofenadine HCL | A-S Medication Solutions | ANDA | Current |
| 55700-848 | Fexofenadine HCL | Fexofenadine HCL | Quality Care Products, LLC | ANDA | Current |
| 55700-848 | Fexofenadine HCL | Fexofenadine HCL | Quality Care Products, LLC | ANDA | Current |
| 59726-564 | Allergy Relief | Fexofenadine HCL | P & L Development, LLC | ANDA | Current |
| 59726-564 | Allergy Relief | Fexofenadine HCL | P & L Development, LLC | ANDA | Current |
| 59726-564 | Allergy Relief | Fexofenadine HCL | P & L Development, LLC | ANDA | Current |
| 59726-564 | Allergy Relief | Fexofenadine HCL | P & L Development, LLC | ANDA | Current |
| 63548-0662 | Childrens Allergy Relief | Fexofenadine HCL | PLD Acquisitions LLC DBA Av | ANDA | Current |
| 63548-0663 | Allergy Relief | Fexofenadine HCl | PLD Acquisitions LLC DBA Av | ANDA | Current |
| 63548-0664 | Allergy Relief | Fexofenadine HCl | PLD Acquisitions LLC DBA Av | ANDA | Current |
| 63629-7997 | Fexofenadine HCL | Fexofenadine HCL | Bryant Ranch Prepack | ANDA | Current |
| 63941-064 | Allergy Relief | Fexofenadine HCL | Best Choice (Valu Merchandisers Company) | ANDA | Current |
| 63941-064 | Allergy Relief | Fexofenadine HCL | Best Choice (Valu Merchandisers Company) | ANDA | Current |
| 63941-064 | Allergy Relief | Fexofenadine HCL | Best Choice (Valu Merchandisers Company) | ANDA | Current |
| 68071-2682 | Fexofenadine HCL | Fexofenadine HCL | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2682 | Fexofenadine HCL | Fexofenadine HCL | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4846 | Fexofenadine HCL | Fexofenadine HCL | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-4846 | Fexofenadine HCL | Fexofenadine HCL | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68554-5061 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Hetero Labs Limited | ANDA | Current |
| 68554-5062 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Hetero Labs Limited | ANDA | Current |
| 68554-5063 | Fexofenadine Hydrochloride | Fexofenadine Hydrochloride | Hetero Labs Limited | ANDA | Current |
| 68788-7449 | Fexofenadine HCL | Fexofenadine HCL | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7449 | Fexofenadine HCL | Fexofenadine HCL | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7449 | Fexofenadine HCL | Fexofenadine HCL | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 68788-7449 | Fexofenadine HCL | Fexofenadine HCL | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 69230-300 | Fexofenadine HCL | Fexofenadine HCL | Camber Consumer Care | ANDA | Current |
| 69230-300 | Fexofenadine HCL | Fexofenadine HCL | Camber Consumer Care | ANDA | Current |
| 69230-301 | Fexofenadine HCL | Fexofenadine HCL | Camber Consumer Care | ANDA | Current |
| 69230-301 | Fexofenadine HCL | Fexofenadine HCL | Camber Consumer Care | ANDA | Current |
| 70934-601 | Fexofenadine HCL | Fexofenadine HCL | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 70934-610 | Fexofenadine HCL | Fexofenadine HCL | Denton Pharma, Inc. dba Northwind Pharmaceuticals | ANDA | Current |
| 71205-531 | Fexofenadine HCL | Fexofenadine HCL | Proficient Rx LP | ANDA | Current |
| 71205-531 | Fexofenadine HCL | Fexofenadine HCL | Proficient Rx LP | ANDA | Current |
| 71335-1217 | Fexofenadine HCL | Fexofenadine HCL | Bryant Ranch Prepack | ANDA | Current |
| 71626-502 | Allergy Relief | Fexofenadine HCL | Medstone Pharma LLC | ANDA | Current |
| 71626-502 | Allergy Relief | Fexofenadine HCL | Medstone Pharma LLC | ANDA | Current |
| 71626-502 | Allergy Relief | Fexofenadine HCL | Medstone Pharma LLC | ANDA | Current |
| 71626-502 | Allergy Relief | Fexofenadine HCL | Medstone Pharma LLC | ANDA | Current |
| 71626-502 | Allergy Relief | Fexofenadine HCL | Medstone Pharma LLC | ANDA | Current |
| 71626-502 | Allergy Relief | Fexofenadine HCL | Medstone Pharma LLC | ANDA | Current |
| 72090-061 | Fex-Allergy Relief | Fexofenadine HCl | Pioneer Life Sciences, LLC | ANDA | Current |
| 72189-305 | Fexofenadine | Fexofenadine | DirectRx | ANDA | Current |
| 72789-196 | Fexofenadine HCL | Fexofenadine HCL | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-196 | Fexofenadine HCL | Fexofenadine HCL | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 72789-196 | Fexofenadine HCL | Fexofenadine HCL | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |